HemoDoc, From Doctor to Patient

The Dialysis Dilemma: What Would Scrib Do?

By Peter Laird, MD

Despite the demonstrable progress in recent years delivering the message of optimal dialysis, from time to time, a very negative portrayal of dialysis emerges in the popular press that paints a shaded picture of the true miracle of hemodialysis that today sustains two to three million people around the world.

I was quite disappointed to read  a recent article that ended on just such a sour note of despair with dialysis despite celebrating the stories of both Bill Peckham and Nancy Spaeth who have graced the world with lives well lived despite ESRD. After all, both Bill and Nancy are still working and contributing greatly to their families, friends and community. It appears that the author of this article failed to capture the true miracle of saved lives with hemodialysis with their example she noted, but does not appear to truly understand.

The dialysis dilemma: urgent need vs. overtaxed system

A HALF CENTURY ago, nobody predicted so many people would have end-stage kidney disease. Or that treating it, per patient, would be one of government's most expensive entitlements.

Now, nephrologist Kelly says, the problem isn't picking which patients should get dialysis; it's that doctors, patients and families seem unable to pick which patients shouldn't.

A few months ago, at a NKC celebration, he called for reconstituting "The Committee" — albeit with a 180-degree change in its mission. It was a moment to pause.

Kelly fervently believes that health care is a right. But he also thinks dialysis has gone too far.

Unfortunately, the story of dialysis today is not that it has gone too far, but that it has not gone far enough. Hemodialysis machines operate in much the same fashion as they did when the doors to renal replacement therapy swung open with the ESRD program in 1973. Since that time, despite the technological revolution that we have seen throughout modern medicine with improved survival from technological advance, the basic components of hemodialysis remain remarkably the same. Although even here there are indeed improvements in buffers, hollow fiber tubing, software, and other aspects of delivering the provision of dialysis, one aspect that has not seen any improvement in hemodialysis is improved outcomes.

The for-profit dominated dialysis industry has focussed their efforts on improving the bottom line of corporate profits but as an industry they have not advanced the technology to improve outcomes in any sensible fashion. In this regard, dialysis has not gone too far at all. Nevertheless, Dr. Kelly is speaking of the ethical dilemmas of open access to this expensive care and not the need for further technological advances.

The dialysis dilemma: urgent need vs. overtaxed system

 Today, with the door to dialysis swung wide open, Kelly argues, doctors, families and patients need a committee because someone, somehow, has to say no.

He battles with himself out loud. "I think, 'Am I some kinda Hitlerian guy, that I want to stop all these treatments?' "

Then he recalls "Scrib," Scribner himself, fearlessly insisting that uncomfortable, tough issues be aired. "I frequently say, when I'm dealing with a case, 'What would Scrib do?' " Kelly says.

"I'm trying to do the right thing — what I think is the right thing."

The study of medical ethics can be summed up simply enough as doing the right thing in difficult circumstances. I am pleased that Dr. Kelly seeks the wisdom and knowledge that "Scrib" would advise America in these trying times. However, seeking to return to "God committees" more properly called death panels from his description is not the avenue that I believe Scrib would venture with the so called "dialysis dilemma" we face today.  Dr. Christopher Blagg wrote a touching and informative tribute to his lifelong friend and colleague shortly after Dr. Scibner's untimely death in 2003. One short paragraph in this tribute speaks loudly on where I believe Scrib would want us to go:

Belding Hibbbard Scribner - Better Known as Scrib

Scrib always said he had been lucky all his life, but he was successful because of his perseverance in problem solving and his delight in tinkering with devices. He was a great teacher and leader and a generous person. His first concern was always for patients, and his other major concerns included for-profit dialysis, the future of U.S. medicine, and the future of the world.

I believe Dr. Blagg characterized best "what would Scrib do?" by noting his devotion to patients first and foremost coupled with his ability for problem solving. The great tragedy of dialysis is not that we have too many patients in need of this life saving technology,  but instead that we have spent too little time problem solving and tinkering with  any new technology. Modern technology seems to have side-stepped the dialysis industry as it ground the constant drumbeat of profiteering above and beyond the love of the patients they serve truly giving a new definition to blood money.

What would Scrib do? I believe he would tinker and problem solve with newer and improved technology and freely give that technology to medicine for no profit of his own as he did with the Scribner Shunt. Instead of profiting millions of dollars personally by his new invention, Dr. Scribner freely gave this life saving device to the entire medical community which is an ethic sadly missing today.

I don't believe that Nancy Spaeth and Bill Peckham wish to be known for an article essentially calling for death panels in the current world of re-engineering dialysis. Instead, they are filled with courage and devotion to this modern medical miracle made possible by a humble man. Where is our present day teacher and leader who shall advance the provision of dialysis in the same spirit of saving lives as both Bill and Nancy testify daily? Both knew and loved Dr. Scribner who served not only as a mentor, encourager and teacher, but as their lifelong friend. Dr. Scribner did not heed the modern admonition of doctors not getting attached to their patients, he instead embraced them with all of his heart and mind and soul.

How many nephrologists today have patients that will outlive them? Even Dr. Scribner's very first patient, Clyde Shields,  lived for over eleven years before cardiovascular disease claimed his rejuvinated life. The amazing panel of Dr. Scribner's patients have lived lives testifying of this truly remarkable invention. (here, and here)

I believe he would approach all patients with severe renal impairment with a courageous strength to save lives above all other concerns. Has dialysis gone too far? No, not at all. It has instead failed to advance far enough that the provision of dialysis is still far too excessively expensive and strangled by an industry that cares first and foremost about reaping ever enlarging corporate profits. What would Scrib do? I believe Dr. Blagg told us quite clearly in his loving tribute that he would focus on the patient tinkering with new technology and giving it all freely away to save lives. Yes, that is what Scribner would not only do, but that is what he did. 

The DaVita Difference: The Transfusion King

By Peter Laird, MD

The major concern voiced about the renal bundle prior to implementation was withholding needed medications to maintain basic vital processes. The renal bundle is largely due to the abuse of EPO for the maintenance of hemoglobin levels in dialysis patients. Erythropoietin comes from health renal tissues that are absent in the majority of patients on hemodialysis with the exception of many with polycystic kidney disease. Under the renal bundle, EPO went from a separately billable income generator to a cost center for dialysis centers.

In the latest USRDS report noted by Gary Peterson on RenalWeb, blood transfusions increased throughout the industry, but the greatest increase is among patients at DaVita, a for-profit dialysis company.

"Since adoption of the bundled payment system, the number of transfusion events has increased, reaching 24 percent by September, 2011. Some providers are associated with a significant increase in transfusion rates over the one-year time period (the rate increased 46 percent in DaVita units), while others show minimal changes (4 and 7 percent in Fresenius and hospital-based units, respectively)."

Looking at further indicators of why DaVita has such an outrageous transfusion rate, one of the answers to that issue is not only in the 37% reduction of EPO use, but much more in their concomitant severe reduction of IV iron products by a factor of 42%.

Tracing the history of EPO abuse at DaVita leading to the moniker, the King of EPO, their gratuitous allegiance to profiteering, now evidenced by the 46% increased transfusion rate is nothing short of a shocking indictment of this company and their business plan. We all understood that the renal bundle would dramatically lower the usage of EPO, but the majority of practitioners expected an increased usage of IV iron products to maintain quality of life in dialysis patients.

Scott Rasgon at Kaiser Sunset maintained stable Hb levels with simple over the counter Vitamin D-3 supplementation while greatly reducing EPO usage. I have been fortunate to maintain my Hb levels with IV iron supplementation for nearly six years of dialysis to date. Patients understand well the quality of life issues associated with higher Hb levels. Sadly, there are absolutely no studies comparing the risk and benefits of EPO to the risk and benefits of transfusions.

Since transfusions are no longer allowed in many free standing dialysis units, hospitals and third party insurance companies pick up the tab on most of the transfusions that DaVita generated since implementing the bundle. This may make great business sense for DaVita generating further profits for their investors, but it makes no sense at all for the dialysis patients suffering with such severe anemia that they need such a large number of transfusions. As a practicing physician, I readily understood the risks of blood transfusions not the least of which is the risk of transmissible agents such as hepatitis and HIV. It was my goal to minimize the need for transfusions whenever possible.

Alan Nissenson has promoted the benefits of the DaVita model securing high quality of care as their model. In this instance, I must challenge their allegations of high quality care when they not only severely reduced EPO usage, but also withheld IV iron which is an effective and safe alternative and adjunctive therapy for renal associated anemia. I am sure that this has greatly increased DaVita profits, but at what expense to their patients.

Pushing Organ Procurement Ethics Over the Slippery Slope

By Peter Laird, MD

The dead donor rule serves organ donors protecting those that can no longer speak for themselves. Tragic cases of death by organ donation are not talked about especially in the renal community yet they are documented and continue to occur in large part due to the lack of uniform brain death criteria throughout the US. Though fortunately rare in occurrence, anyone that has seen the NBC news report on the Zack Dunlap case should seek legislation assuring that no one would ever die as a result of death by organ donation. (here)

Unfortunately, coupled with paradoxical outrage at a Wall Street Journal article documenting the rare cases of death by organ donation, medical ethicists recently turned the discussion to procuring organs prior to the death of the donor. Although there were some ethicists who spoke against this newly proposed donation policy, many supported this new medical ethics paradigm.

The Case for Kidney Donation Before End-of-Life Care

Donation after cardiac death (DCD) is associated with many problems, including ischemic injury, high rates of delayed allograft function, and frequent organ discard. Furthermore, many potential DCD donors fail to progress to asystole in a manner that would enable safe organ transplantation and no organs are recovered. DCD protocols are based upon the principle that the donor must be declared dead prior to organ recovery. A new protocol is proposed whereby after a donor family agrees to withdrawal of life-sustaining treatments, premortem nephrectomy is performed in advance of end-of-life management. Since nephrectomy should not cause the donor's death, this approach satisfies the dead donor rule. The donor family's wishes are best met by organ donation, successful outcomes for the recipients, and a dignified death for the deceased. This proposal improves the likelihood of achieving these objectives.

As a renal disease sufferer, I initially considered pre-emptive renal transplant with donation from my wife. However, after considering both my prior history of cancer and risk of cancer recurrence after renal transplant and the risks entailed for my wife, I declined to pursue that option and then focused on optimal dialysis considerations. After all, renal disease is my disease and my responsibility. I do regret the loss of the kidneys that God granted to me, but I do not believe I have any right to another persons kidney whether dead or alive. It is a gift, it is not a right of any person with renal disease. 

It appears to me that in many ways, the renal community has transformed renal donation into a right over the last two decades. Presumed consent at its heart gives ownership of vital organs by the state for all those that don't opt out of this system utilized in Spain and other nations. While I value the gift of organ donation, I still cherish my civil liberties and I would hope that the demand for renal donation would never preclude our right to liberty and self determination. Once again, it is my disease, not someone else who is a complete stranger to me who has their own right to life, liberty and the pursuit of happiness.  In many ways, I personally would much rather die from my renal disease than see my renal disease used as a means of of encroaching another man's civil liberties.

I fear that I am in the minority opinion among my friends and colleagues in the renal community. It appears that just about any means of increasing renal donation no matter what the ethical implications of those policies and procedures is gladly welcomed by the renal community at large. Presumed consent, abandonment of the dead donor rule, donation by cardiac death and now kidney donation before end of life care infringe civil liberties for society in general and push the organ procurement ethical framework over the slippery slope endangering individual societal rights.

While I am sure that I will likely be in the minority opinion on this issue among the renal community, I must still question whether there are limits we should not cross in providing all available ethical renal donations? Changing the definition of what is ethical is a dangerous slippery slope that poses risks to society at large. Should we not who are most at risk in this society from our own renal disease support the protection of others who can no longer speak for themselves in their own tragic circumstances and forgo our greed for their organs by ever changing medical ethics?

American society decades ago saw the dangers of euthanizing anencephalic children and harvesting their organs recognizing the sanctity of person-hood in these children doomed to a sure death shortly after birth. I suspect our current modern society will re-evaluate that decision as well one day. I don't see these changes in our medical ethics as a positive change in any manner. I believe it shows a callous disregard of our human condition and respect and dignity for the individual and life in general.

We in the renal community must consider that same callous disregard for individual lives could in the end be the same sort of justification given to terminate treatment of those with renal disease as well. We are on the high price, low benefit scale according to many medical ethicists with some questioning how we perform dialysis in America. (here)  The renal community needs to be very careful what we ask for as there are always consequences of seemingly small decisions. 

Donation prior to death should never be the standard for organ procurement. I would hope that the renal community would understand this better than the general population since it was the respect for individual life that spurred the 1973 ESRD program funding in the first place. Losing this fundamental ethical paradigm could have untoward outcomes on continued ESRD funding in the future. The demand for kidneys today should not subvert the ethical foundations that secure our future especially in a time of limited resources.

I personally call upon the renal community to stand up and firmly disengage from the pursuit of renal donors at any cost through alteration of long held ethical paradigms. I would hope that the renal community will instead reaffirm the dead donor rule and set limits on the ethics of organ procurement. Respect for all life begins by recognizing the importance of the individual no matter what circumstances they encounter. Is that not the story of the ESRD program in 1973? If we won't stand up for those at risk of death from trauma and other illnesses, who will stand up for us in our time of need that the future shall surely bring.

Confessions of a Nephrologist: Is Withholding Information Part of the Art of Medicine?

By Peter Laird, MD

As a practicing internal medicine specialist, applying the legal requirement of informed consent at times appeared to be an act of absurdity with many common ailments. I clearly documented and performed the legally required informed consent many times over for treatments as mundane as ear infections and other illnesses that often times are self limited and would resolve without any treatment at all rendered. Comfort of the patient at times became the motivating force behind these treatments. For myself and my colleagues, the complaint of negligent care by tort law most often came in the failure of proper informed consent or lack of informed consent. The legal basis of informed consent is summarized well in an essay on this subject:

An Empirical Analysis of the Medical Informed Consent Doctrine: Search for a "Standard" of Disclosure

The prototypical informed consent case arises when a patient suffers an injurious, nonnegligently-caused outcome of a diagnostic or therapeutic medical procedure.20 An outcome that is nonnegligently caused is one which arises in a certain percentage of cases regardless of the care of the physician, due to physiological differences from the norm or particular susceptibilities of a patient, or one that arises from an act or failure to act of the physician but such act or failure to act is within the standard of care.21 In order to recover damages for that outcome, the plaintiff must establish the elements of negligence, that: (1) the physician had a duty to disclose particular information to the patient; (2) disclosure did not occur; (3) (a) but for the nondisclosure, the tendered procedure would have been refused, and (b) that the tendered procedure was the cause in fact of plaintiff's injury; and (4) the plaintiff suffered a compensable injury.22

The legal requirement is that all medical treatments must be understood and accepted by the patient or the legal guardian and consent to each medical intervention. The risks, benefits and alternative treatments must be explained and in addition, the physician must ascertain that the patient understood these issues. I have read and heard my colleagues in the various specialties spell out very specific risks and benefits that were then duly documented in the medical record, many in precise and at times graphic detail. Many surgical specialists have gone so far as to video tape standardized informed consents for routine procedures such as elective hip replacements and having the patient attend pre-surgical patient education classes. In these classes, all conceivable outcomes and expectations are listed with documentation of pertinent studies when indicated.

Since entering the world of American style dialysis, the first culture shock I encountered was the number of decisions made by the medical team with little clear and precise informed consent such as sodium modeling or ultrafiltration rates for instance. Because the legal standard for informed consent is a community standard, all that a nephrologist must do to meet that requirement is to do what the average nephrologist would discuss and advise. Sadly, the record for the American nephrology community is greatly lacking compared to all other informed consent procedures I have encountered in my professional life as a physician. Several surveys have documented this unique American nephrology failing:

Patient education and access of ESRD patients to renal replacement therapies beyond in-center hemodialysis

RESULTS: Substantial proportions of patients were unaware of their kidney disease (36%) or were not seeing a nephrologist (36%) until <4 months before first dialysis. The presentation of treatment options was delayed (48% either after or < 1 month before the first dialysis). The majority of ESRD patients were not presented with chronic peritoneal dialysis, home hemodialysis, or renal transplantation as options (66%, 88%, and 74%, respectively). Using multivariate analyses, variables significantly associated with selection of chronic peritoneal dialysis as dialysis modality were the probability of chronic peritoneal dialysis being presented as a treatment option and the time spent on patient education.

CONCLUSION: An incomplete presentation of treatment options is an important reason for under-utilization of home dialysis therapies and probably delays access to transplantation. Improvements in and reimbursement for pre-ESRD education could provide an equal and timely access for all medically suitable patients to various RRTs.

Many patients falsely enter into the dialysis unit believing that conventional in-center dialysis will restore and extend their lives significantly. In my opinion, the American nephrologist fails miserably in the standards of informed consent that I practiced and observed in all aspects of my medical career. Similar studies subsequent to Mehotra's study reveals no improvement in this situation. Sadly, one of the rare randomized and controlled dialysis trials is essentially ignored today despite a significant finding of increased self care dialysis choices for those with improved informed consent:

The impact of education on chronic kidney disease pateints' plans to initiate dialysis with self-care dialysis: a randomized trial

Methods Seventy patients with CKD who were receiving care in a multidisciplinary predialysis clinic were randomized to receive either (1) a two-phase patient-centered educational intervention (phase 1 included educational booklets and a 15-minute video on self-care dialysis; phase 2 included a 90-minute small group interactive educational session on self-care dialysis) in addition to their regular multidisciplinary care, or (2) ongoing standard care and education in the multidisciplinary predialysis clinic. The primary outcome was patients' intention to initiate dialysis with self-care dialysis, assessed by questionnaire.

Results Thirty-five patients were randomized to standard care; 34 completed the study. Thirty-five patients were randomized to the educational intervention; 30 completed phase 1 and 28 completed phase 2. By study end, significantly more patients in the intervention group (82.1%) intended to start dialysis with self-care dialysis compared with the standard care group (50%, P = 0.015). This difference persisted after controlling for the small baseline differences among patients in the two study groups (P = 0.004).

Conclusion A two-phase educational intervention can increase the proportion of patients who intend to initiate dialysis with self-care dialysis.

Despite the positive findings of a randomized and controlled trial increasing patients choice of self care dialysis and the dismal record the American nephrologist has accomplished in the area of informed consent, the intractable attitudes among nephrologists has not budged. I have wondered for several years now how this dichotomy between American nephrology and the other specialties is so diverse and uniformly ignored by this specialty.  I have been puzzled even more so is the complete lack of accountability for ignoring such a fundamental fiduciary physician responsibility with few if any consequences for this failure. After all, informed consent is required by law for dialysis patients:

§ 405.2138   Condition: Patients' rights and responsibilities.

The governing body of the ESRD facility adopts written policies regarding the rights and responsibilities of patients and, through the chief executive officer, is responsible for development of, and adherence to, procedures implementing such policies. These policies and procedures are made available to patients and any guardians, next of kin, sponsoring agency(ies), representative payees (selected pursuant to section 205(j) of the Social Security Act and subpart Q of 20 CFR part 404), and to the public. The staff of the facility is trained and involved in the execution of such policies and procedures. The patients' rights policies and procedures ensure at least the following:

(a) Standard: informed patients. All patients in the facility:

(1) Are fully informed of these rights and responsibilities, and of all rules and regulations governing patient conduct and responsibilities;

(2) Are fully informed of services available in the facility and of related charges including any charges for services not covered under title XVIII of the Social Security Act;

(3) Are fully informed by a physician of their medical condition unless medically contraindicated (as documented in their medical records);

(4) Are fully informed regarding the facility's reuse of dialysis supplies, including hemodialyzers. If printed materials such as brochures are utilized to describe a facility and its services, they must contain a statement with respect to reuse; and

(5) Are fully informed regarding their suitability for transplantation and home dialysis.

Once again, for each specialty, it is a community standard set by the specialists themselves of what an average nephrologist believes his patients need to hear. For the American nephrologist, CMS spells out in great detail what is required. It appears that there may be more philosophical barriers to true informed consent amongst the American nephrology community as evidenced by a posting by Dr. Ajay Singh on his The Kidney Doctor blog:

Dialysis Unplugged: Compassionate Withholding of Information, Damned if You Do, Damned if You Don't

I can tell you right off the bat that I do not routinely tell my patients starting dialysis that on average they have a 20% chance of dying in the first year of starting dialysis. Nor, for that matter, do I tell my 70 year stage 5 CKD patient, who I am preparing for  initiation of dialysis, that she or he has, on average, 2 to 3 years longevity of dialysis. Of course I want to be truthful to my dialysis patients, but averages are misleading, and ESRD is not a terminal disease. Moreover, two or three additional years of life aren’t something to ignore. . . 

Here’s where I disagree. Linda Emanuel is taking what is often a complex situation and simplifying it. Worse still, she is arguing that deliberate withholding of information is unethical.  Of course we all agree that we need to provide a realistic assessment of prognosis to our patient’s and their families. However, there is a fine line between “realistic assessment” and “scaring people”. This is where knowing the patient and their family and applying the Oslerian “the art of medicine” comes into play. Compassion is important (read this story to know why). For example, I don’t tell all my dialysis patient’s that their prognosis is worse than if they had some forms of cancer. It might be on average, but it is certainly not true for everyone. Dr. Paul Beeson once said: “Our profession, after all, deals partly with guess work; we do not deal in absolutes.”

I am frankly appalled at the open disregard by a prominent American nephrologist in not explaining the most basic aspect of ESRD, that of mortality with conventional in-center dialysis care to each and every competent patient. I find this completely at odds with my entire medical training and practice and that of my colleagues in high risk specialties where adverse outcomes are common.  The most important information that a patient and their family needs is exactly what sort of illness and outcomes they are dealing with at the onset of treatment. The issue of informed consent becomes even more apparent with the publication of intensive dialysis outcomes in JASN today showing significant survival benefits for these renal replacement therapy options. For patients that never hear of the grave risk of death from ESRD, what will motivate patients to seek treatment options that entail sacrifice and great personal effort to accomplish?

In my opinion, the slothful approach to informed consent amongst the American nephrology community is at great odds with many recent studies proving the benefits of alternative dialysis treatment options. If the American dialysis hegemony will ever end, it must first start with a paradigm shift in the attitudes of American nephrologists towards their patients and incorporate respect for patient autonomy into their daily practice much more so than is evident today. It is my opinion and that of available evidence based medical studies on informed consent in the American dialysis industry that change is needed.  It must begin one nephrologist at a time. After all, if the American nephrologist is too ashamed to relate mortality to dialysis patients, they may wish to consider modalities that improve this dismal result with each and every competent patient. After all, it is the law.

Dialyzing at Home Alone: Is There Not a Cause?

By Peter Laird, MD

Dialysis in America is different than the other developed nations. The focus in America is very much industry centric instead of patient centric. One of the most profound examples of the differences between dialysis in the United States and other developed nations is the nearly universal prohibition against patients dialyzing at home alone. Canada, England and Australia not only allow patients to dialyze at home alone, the entire focus in those nations is on self care as a responsibility of the patient and not the care takers.  There are many barriers to dialyzing at home alone including companies such as NxStage which included the provision of a care partner in their FDA approval as well as dialysis providers. Some States also prohibit dialyzing at home alone.

Physicians bear the brunt of the responsibility in ensuring safe dialysis practice. From my own experience, the overwhelming impression among my colleagues in internal medicine is that dialysis is a dangerous procedure. Certainly, it is an invasive procedure but I believe the instinctive reaction of most physicians including nephrologists comes from the iatrogenic complications seen daily in dialysis units where patients routinely collapse from rapid volume depletion due to excessive ultrafiltration rates. The stable dialysis patient is a foreign consideration in most dialysis units. The reaction of most providers when discussing dialyzing home alone is as astonishing as Macaulay Culkin's iconic realization he was home alone.

When I first started dialysis, I was surprised that I survived each treatment when I considered my own professional bias against dialysis learned in the intensive care units where more than one dialysis patient "crashed." As I learned more about optimal dialysis and applied that knowledge to my own treatments, I slowly realized that the philosophical approach and application of treatment is the most important stabilizing factor. In five years of dialysis, I have never once vomited, passed out or even become lightheaded except for the one time that my dialysis technician set my ultrafiltration for 5000 ml instead of 500 ml. After 2.3 liters, I began to be nauseous and lightheaded. Two liters of normal saline reversed that medical error.

Bill Peckham recently celebrated ten years of home hemodialysis, nine of which have been self dialyzing home alone. The benefits of home dialysis far outweigh any associated risks especially when compared to the risks of standard care. In the time Bill has been dialyzing self sufficiently, he has accomplished more than many people accomplish with intact kidneys. This is a picture of Bill dialyzing on board his boat that he captained north of Seattle.  For the average nephrologist practicing in America, Bill would be a nightmare of medical legal risk in their skewed views of the usual dialysis patient. Living a life well is a goal all of us have.  Adding the burden of renal disease makes this endeavor a daily struggle, but the example that Bill has set for the entire renal community should not go unnoticed. I must confess that the idea of strapping a generator and a dialysis machine to an inflatable white water raft going down the Rogue River is not my idea of a self care dialysis unit. But the truth is that this is not only possible, but it is safe. In fact, dialyzing on terra firma with a generator in many ways is much safer than floating down a wild river on a piece of rubberized plastic. (here)

 

With the resurgence of home hemodialysis after decades of suboptimal dialysis care languishing in for-profit dialysis units, the plight of those who are capable of self care yet are hindered by arbitrary standards requiring a care partner is a cause worth fighting. It is time to evaluate the stable dialysis patient and note that life itself is not risk free, but it is worth living well. For patients on dialysis, living well in many ways means taking charge of your own care at home. As the market place opens the door to thousands of new home hemodialysis patients, the American dialysis industry needs to grow with their patients as they overcome their own fears and anxiety inherent in doing self care. The last issue a patient needs in this circumstance is physicians and providers more concerned about their own anxiety over dialysis. The reality is that dialysis can be safe and stable even when dialyzing home alone not only in Canada, England or Australia, but right here in the United States as well.

The Silent Suffering of Dialysis

By Peter Laird, MD

They say that a tree that falls in the woods make no sound. The philosophical sophomoric discussions of college life have long since passed and have given way to the tasks of daily survival wonder when and if I shall fall myself. On that day, will my demise as a tree in the woods reaching the end of bearing its own wait be met with silence or shall a bit of the universe notice that passing of another of God's creatures.

Last Wednesday, I reminded myself of why I am so fortunate to dialyze in the comfort of my own home. My own headache, queasy stomach, foggy thinking and fatigue was all encompassing to my own soul, yet through all of my own rather pitiful self absorption for having to endure three hours of conventional in-center dialysis was tempered by two lonely souls crippled by the ravages of unrepentant renal disease. On my left, the open chair soon became a source of commotion as two burly ambulance attendants brought the resident of that chair in on a gurney. She never spoke the entire time I was beside her. I had wondered if she was comatose but when the nurse came and silently inserted her needles, she did whimper in pain. About two hours later as the ultrafiltration drained her debilitated body, I heard her one more time moan from presumed cramping.

Tonight I had one of the worst episodes of cramping in  both my calfs. For me, cramping is entirely my own fault for not drinking enough fluids during the day and beginning my dialysis session dehydrated.  I take only 300 ml  from ultrafiltration since I am fortunate to still have significant residual urine function. The memory of my neighbor beside me had already faded from my memory until the sharp pangs of an early cramp warned me of what was to follow. Fortunately, I learned years ago to tell my patients to simply stand and put all their weight on their legs to relieve a cramp in the calf. I remembered my elderly father while I was in medical school suffering from the effects of dehydration after working all day on a windmill garage he designed and essentially built single handed. On that day, I didn't know enough to tell my dad just to stand up. Instead, I can still see him sitting on the floor fallen to the ground unable to do anything but wait until the pain passed.

My neighbor on the right of me in the dialysis unit had no legs and he likewise was silent the entire dialysis session. Except that is until his ultrafiltration levels reached the point where he too began to moan in the agony of a cramp in the stumps that were once healthy and strong legs. I had noticed that he had a small white cloth in his hand. I didn't know what it was for until he began to writhe silently in the first stages of his cramps. He had been through this before and was prepared. I have seen many an old western movie where the doctor gives the patient a cloth to bite down on as they perform an operation without anesthesia. This was the first time in my entire life I actually witnessed a man muffle his own screams with cloth in his mouth.

During this entire time, I never saw a nurse, a doctor, a tech or anyone at all stop their busy gossip and attention to the charts to comfort these two suffering silently in their own way. We can certainly talk about futile and expensive care, but obviously these two broken people still had an unbroken will to live which in the end is the only question we need to answer on whether people should submit to this frequent torment. No one who could intervene and massage the stumps of this man ever appeared to hear anything at all. To them, the sufferings of these two people were completely silent.

The answer to whether a tree makes a sound if it falls in the woods is you must have an observer hear the disturbance in the air that physics tells us occurs every time.  I don't know what the solution will be to the silent suffering of thousands of patients every day in dialysis centers, but I know one thing, their suffering did make a noise. I know because I not only heard it, but the noise was so loud and disturbing I felt their silent anguish deep in my own heart. Perhaps one day, the nurses and techs will one day wonder the same thing, does a tree make a sound when it falls in the woods? I hope for their sake that they have someone that heard the noise that will always happen when a soul is in anguish.

 

Was the FHN a Waste of Research Effort and Expense?

By Peter Laird, MD

The Frequent Hemodialysis Network Trial Group came into existence after calls from Glenn Chertow and others declared the need for definitive randomized and controlled trials to eliminate bias which may confound results of observational studies. Several prominent nephrologists including Belding Scribner opposed this study noting the preponderance of conclusive benefits of more frequent and longer duration dialysis modalities rendering randomization to conventional vs "high-intesity" therapy unethical.

"Wishing Don't Make it So" _ Why We Need a Randomized Clinical Trial of High-Intensity Hemodialysis

Despite the paucity of data, some advocates of high-intensity hemodialysis have argued that an RCT comparing conventional versus high-intensity therapy should not be performed because high-intensity therapy is so clearly superior to conventional therapy so as to render such a study unethical. Others argue that a registry of patients treated with high-intensity hemodialysis and examined using techniques of observational data analysis will so clearly demonstrate the superiority of the technique and that an RCT would be a waste of research effort and expense. I find these arguments fully unsatisfactory. Although few would doubt the economic importance of erythropoietin dosing or the potential clinical benefits that might be gained with better control of hypertension, anemia, hyperphosphatemia, and endocrinopathies, modest changes in these intermediate outcomes are hardly sufficient to warrant a profound change in practice and an enormous increase in the expense of hemodialysis. Moreover, although high-intensity hemodialysis may improve health-related quality of life in selected individuals, it may have dysutility in others in relation to the increase in direct time and effort involved. To answer the fundamental questions of whether high-intensity hemodialysis improves outcomes, and if so, by how much, we should move forward with an RCT. 

High-Frequency hemodialysis: Rationale for Randomized Clinical Trials

These RCT will provide the best available evidence on the safety and the efficacy of high-frequency hemodialysis. Although their limited size will make it infeasible to measure mortality as an independent primary outcome, these trials will provide the strongest evidence available on the effect of frequent dialysis on the domains of care that are most important to dialysis patients. Although these trials may not answer all questions definitively, they will give us far more dependable information than we now have with observational studies alone. Many authors of the published observational studies agree: They are the very investigators and clinical centers that are participating now in these trials. Our patients are expressing their trust in us and in the importance of an RCT by their enrollment. We trust that the results in multiple domains will give the nephrology community of patients, clinicians, and policy makers substantially better data for clinical and policy decisions. 

Since the publication of the short daily dialysis treatment arm of the FHN,  many would rightly argue in my opinion that little has changed in the dialysis setting as a result of this study.  We can certainly note that many of the lead authors of the FHN have not promoted daily dialysis as the best practice change even with these positive findings.  Despite the profound recruitment difficulties, more frequent hemodialysis provided significant improvement in the measured quality of life indicators and left ventricular hypertrophy in this study which met the goals in the proposed power analysis.  It further confirmed the findings of Culleton et al, with reduction of LVM from more frequent nocturnal dialysis compared to conventional in-center hemodialysis.  These two RCTs confirm the several decades of observational studies showing benefit to more frequent and longer duration dialysis.

A year after the publication of the FHN short daily dialysis trial, the FHN trial group published the alleged  "negative" findings of the nocturnal trial. This trial was severely hindered by it's recuitment difficulties. Instead of scrapping this study all together, they instead tried to salvage it with several revisions to the original study protocol including reducing the number of patients from 250 down to the final 87 enrolled, eliminating the requirement of the control group only doing in-center hemodialysis and allowing home dialysis on a convential thrice weekly schedule as part of the control group, and perhaps most importantly, liberalizing the requirement for patients to have a GFR less than 3ml/min per 1.73 m² to that of less than 10 ml/min per 1.73 m^2.  

The Effects of Frequent Nocturnal Home Hemodialysis : Materials and Methods

The residual renal function exclusion criterion was higher in the FHN Nocturnal Trial than in the FHN Daily Trial (>10 ml/min per 1.73 m² as calculated as the average of the urea and creatinine clearances versus >3 ml/min per 1.73 m² of urea clearance, respectively)^[21] as it was anticipated that the dose separation would be greater in the Nocturnal Trial.

Since one of the main measures of the FHN nocturnal study was the left ventricular mass of the trial subjects coupled with the known relationship of volume status as one of the primary causative factors in developing LVH in the dialysis population, liberalizing baseline exclusionary GFR to >10 ml/min per 1.73 m^2.  introduced a confounding error within this study that may have rendered any useful information of it's outcomes a complete "waste of research effort and expense." In a recent editorial on the FHN studies by some of the lead authors, they acknowledge the recruitment difficulties and the confounding error it presented:

Should the knowledge gained from the Frequent Hemodialysis Network (FHN) trials change dialysis practice?

Therefore, although the interdialytic volume loads were similar in the more frequent arms of the FHN Daily and Nocturnal studies, the interdialytic volume loads in the conventional arms were lower in the FHN Nocturnal study than in the FHN Daily study.

Dr. Rocco and his two esteemed colleagues went on to offer their advice on how to change dialysis practice in America not by more frequent hemodialysis, but instead by dietary modification and more aggressive ultrafiltration. In doing so, these lead authors of the FHN chose treatment paradigms documented in retrospective, observational studies, some of which are more than 13 years old which in my opinion is complete hypocrisy of the rationale for the FHN in the first place:

Should the knowledge gained from the Frequent Hemodialysis Network (FHN) trials change dialysis practice?

In terms of practice change, it could be argued that the major effect of the trial on LVM could be accomplished by appropriate dietary counseling and modification of dialysis practices. An example of a feasible change in practice pattern is a reduction in the amount of sodium given during dialysis, which could be accomplished by reduction of the dialysate sodium concentration with reference to that of the patient, less saline administration to the patient during priming and the use of hypertonic glucose for hypotensive episodes[22]. 

I believe it is time, in my own personal opinion, to put the FHN nocturnal study in its proper place. That of the great wall of shame in medical studies. I am embarrassed for those participants of this study who are leading advocates of nocturnal dialysis therapy such as Dr. Pierratos and Dr. Lockridge among others. These doctors continually advocate and promote this lifesaving modality. Yet, today, their message of hope is blunted by what in my opinion is the shameful academic sham presented by Dr. Rocco, Dr. Levin and Dr. Raimann in the preceeding article. If we are to cast away over 10 years of preparation and production of the costly FHN results and instead adhere to a small retrospective, observational trial conducted in Turkey in 1998 utilizing the failed adherence to aggressive ultrafiltration practices, then yes, in my opinion, the FHN was a complete waste of research effort and expense.

(This article is the personal opinion of the author. HemoDoc.com offers the opportunity for rebuttals and dissenting opinions to the author's personal and professional opinions on these issues. Please contact HemoDoc.com if you wish to submit a rebuttal to this article in addition to the opportunity to place respectful comments. All professionally written and appropriate rebuttals will be printed in full with author credits required.)

Will Studies Of Patient "Noncompliance" Justify Cherry Picking?

By Peter Laird, MD

The for-profit dialysis industry is scrambling to put together new strategies on how to maximize their profits in the new CMS Medicare renal dialysis bundled payment system. This is the first time since the inception of the 1973 ESRD program that pay for performance has been part of the reimbursement structure. Even so, it will only put at risk up to 2% of total payments to any center in one year based on anemia management and urea reduction ratio (URR).  With the onset of the QIP in only a couple more months, some in the industry are looking for excuses to avoid the penalties.  A recent study illustrates the frustration that some are expressing about meeting even minimal quality indicators:

Patients who don't follow treatments hurt dialysis clinics' pay

Recently, Medicare implemented a pay for performance program for reimbursing dialysis clinics that provide care to kidney disease patients. One goal consists of achieving adequate dialysis dose (the amount of blood that is purified) in > 96% of patients in every clinic. Therefore, clinics that don't meet the 96% goal would get financially penalized.

Navdeep Tangri, MD (at Tufts Medical Center during the study and currently at the University of Manitoba in Winnipeg, Canada) and his colleagues looked to see if patient characteristics affect whether dialysis clinic achieve this goal. By analyzing electronic health records from 10,069 dialysis patients across 173 clinics and using advanced statistical methods, the researchers found that patient characteristics—particularly how well they followed their prescribed treatments—had a tremendous impact on a facility's achievement of the pay for performance measure. For example, patients who shortened or skipped dialysis treatments or gained weight between treatments played a major role in determining whether dialysis clinics fell short of reaching their goal.

The findings indicate that dialysis clinics that provide care to a greater proportion of patients who don't follow their prescribed treatments—which tend to cluster in low-income urban areas—would get unfairly penalized under the current payment system. "We believe that these penalties may lead to cherry picking against disadvantaged patients, and therefore widen disparities in care," said Dr. Tangri. The authors noted that alternatives to penalizing clinics that care for patients with complex medical and/or social problems are needed.

Unfortunately, cherry picking of the best dialysis patients with employer based health care plans is deeply engrained in dialysis practices already.  No where else in medicine are the rules of patient abandonment pushed to the limits as that of American dialysis units that at times dismiss patients from their units with the only alternative these patients have is to seek treatment at the local emergency rooms.

It is quite easy to be labeled a non-compliant patient. When I traveled to see my parents a year after starting dialysis, the new unit on the first day came to me and bluntly stated, "you refused EPO" based on what was written in my transfer summary. The true story is that I didn't need any EPO with a Hb over 12.0 on iron supplements alone coupled with my prior history of cancer. Not only was EPO not indicated in my case, it was also contraindicated, yet I was labeled by my home unit as a patient who had "refused" EPO which implied an underlying noncompliance. Nothing could be further from the truth. I was instead a well informed patient exercising my right to choose my own treatment options. In many cases, patients who seek to maximize their own treatment choices are quickly labeled non-compliant and documentation to that effect occurs.

On the other hand, the usual in-center dialysis treatment is one of short treatment times and high ultrafiltration rates that cause severe vascular compartment fluid loss rapidly leading to early signs of circulatory collapse and shock with nausea, lightheadedness, dizziness, vomiting, severe cramping and at times hypotension leading to syncope. In many units, supplies are chronically limited and staff are severely overworked. Many patients end a dialysis treatment strapped to an ambulance gurney en-route to the nearest emergency room. Is it any wonder that many patients simply don't want to participate with every scheduled patient given the true torments that they suffer at the hands of those pledged to secure their health.

I am not surprised that the reaction to the QIP is to seek routes of escape from the loss of even 2% of pay for a poor performance instead of seeking to overcome these deficiencies. That was not the intent of the QIP which instead was instituted to improve quality and activate quality improvement processes in the dialysis units. If this article is any indication of the response of the for-profit dialysis industry, then cherry picking appears to be their response to these newly imposed minimal quality standards instead of dealing with these known problems. That would be a sad testimony of our dysfunctional American dialysis industry. Unfortunately, it is the most likely response that we will see.

 

For the Love of Money: The DaVita Investigations

By Peter Laird, MD

Davita continues to encounter more allegations of improper business dealings in civil, state and Federal investigations. (here, here and here)  The allegations are augmented by whistle-blower civil lawsuits recently filed against the dialysis giant. The main thrust of the alleged illegal business arrangements focusses on the issue of improving Davita's bottom line at all costs but doing nothing to improve patient outcomes:

Whistleblowers file suit against dialysis provider DaVita Inc.

"The complaint makes clear that for years, DaVita has used different sets of rules to game the Medicare system and illegally inflate their government reimbursements at taxpayer and patient expense," said L. Lin Wood, attorney for the whistleblowers. "Taxpayers and patients should feel a sense of outrage when they read the complaint and learn how DaVita has become a multi-billion dollar business due in large part to corporate strategies and protocols focused on extracting every dollar possible from the government rather than on improving the care of chronically ill patients."  

The allegations against the dialysis industry as a whole of placing greed and profits above patient outcomes is not new. Belding Scribner, the inspiration behind chronic hemodialysis spoke out against the for-profit dialysis practices that have resulted in the developed world's worst patient outcomes . Dr Scribner spent his last remaining years critizing the emphasis on profits instead of saving lives with this unique technology. Dr. Scribner ironically gave up the riches of his shunt invention and instead focussed on simply saving lives when he gave his shunt freely to the world lending his criticism more relevance:

Belding Scribner: The Inventor of Shunt Dialysis

A less known aspect of Scribner's world-view was his abhorrence for the contaminating effects of the profit motive on medical care. He felt strongly that a physician's commitment to a patient should not be tainted by profits. “He was disturbed that what had been a ‘noble experiment’ was degenerating into a rush for profits,” says Dr Christopher Blagg, professor emeritus of medicine at the University of Washington. “In 1960 it wasn't usual for academic physicians to patent inventions. They sort of gave them away. He joked that if he'd patented the shunt he could have bought an island,” said Dr Blagg. “He was upset that academia was becoming more and more involved with commercial entities.”

Today, many aspects of the American dialysis experience of rapid patient turnover, short treatment times compared to other nations and overly aggressive ultrafiltration are directly attributable to the for-profit dialysis industry which has worse outcomes than the non-profit dialysis providers as noted in a recent study.

Dialysis Center Choice Makes Difference in Death Risk

Newswise — If you need dialysis for advanced kidney disease, where you get it could make a big difference. A large study found that patients in certain large chain facilities are significantly more likely to die than those treated elsewhere. Mortality was also higher in for-profit than non-profit dialysis centers.

“The differences were not minor,” said Yi Zhang, Ph.D., lead study author. “We need to find out what caused them.”

Whatever the outcomes of all of the DaVita investigations is, America is already under an indictment of the love of money more than the love of man in many aspects of health care. In my opinion, the love of money is most noted especially in the American dialysis industry that continues to reap the benefits of huge profits while delivering the highest mortality and worst outcomes of all the developed nations. It is time to place saving lives as the highest goal of dialysis treatment. Americans are not getting their money's worth out of delivering huge profits to these large dialysis organizations that dominate the provision of dialysis today. Many note that where there is smoke there is fire. If so, DaVita certainly may be on fire today.

Troubling Study on Hemodynamic Consequences of Altering Potassium Levels in Dialysate

By Peter Laird, MD

One of the greatest challenges to improving outcomes in hemodialysis patients is reducing the incidence of sudden cardiac death. In fact, more hemodialysis patients die as the result of sudden cardiac death from arrhythmia's than they do from actual myocardial infarctions (heart attacks). Hemodialysis patients also present with different symptoms during a myocardial infarction than those without renal disease and dialysis therapy with less complaints of chest pain and higher risk of cardiac arrest while hospitalized. Yet, the underlying pathophysiology of this observed increased risk of sudden cardiac death remains largely unstudied to date.

In addition to sudden cardiac death, many dialysis patients are at high risk of intradialytic hypotension (IHD) during hemodialysis itself. Elevated ultrafiltration rates higher than 10 ml/h/kg significantly increase the risk of IHD as well as congestive heart failure in the long run. Myocardial ischemia during hemodialysis leads to long standing myocardial stunning and hybernation, all of which predispose patients to increased frequency of hemodynamically significant episodes of IHD, especially in those patients with known congestive heart failure and myocardial fibrosis with left ventricular enlargement (LVH). Any studies evaluating the hemodynamic effects of differing dialysis modalities should include baseline characteristics and intradialytic cardiovascular parameters to ensure the safety of the intervention.  In addition, these types of studies should not include any patients at high risk for poor cardiovascular outcomes.

The study in question evaluated differing potassium levels on hemodialysis patients by testing blood pressure responses and peripheral vascular resistance in three separate dialysis solutions, one point below, one point above and normal potassium dialysate levels. However, the authors did not monitor for myocardial ischemia during the different sessions, nor did they exclude those elderly patients with known risks of sudden cardiac death from underlying LVH.

Haemodynamic consequences of changing potassium concentrations in haemodialysis fluids

Results. Comparing K-1 and K+1, differences were found within the tertiles regarding systolic (+5.3, +6.6, +2.3 mmHg, p<0.05, <0.05, ns) and mean blood pressure (+4.3, +6.4, -0.5 mmHg, p<0.01, <0.01, ns), as well as peripheral resistance (+212, +253, -4 dyne.sec.cm-5, p<0.05, <0.05, ns). The stroke volume showed a non-statistically-significant inverse trend (-3.1, -5.2, -0.2 ml). 18 hypotension episodes were recorded during the course of the study. 72% with K-1, 11% with K and 17% with K+1 (p<0.01 for comparison K-1 vs. K and K-1 vs. K+1). 

Conclusions. A rapid decrease in the concentration of serum potassium during the initial stage of the dialysis obtained by reducing the concentration of potassium in the dialysate translated into a decrease of systolic and mean blood pressure mediated by a decrease in peripheral resistance. The risk of intra-dialysis hypotension inversely correlates to the potassium concentration in the dialysate. 

Unfortunately, despite the well documented occurrence risk of low potassium, none of these high risk elderly patients with a high prevalence of known ischemic cardiomyopathy had any cardiac monitoring for ST depression during dialysis, nor did they follow these patients for hypoxia which low potassium baths are likewise documented causing. In addition, myocardial ischemia and myocardial stunning are likewise induced by low potassium dialysate levels yet the authors once again did not measure these parameters as well. In such, this elderly group of patients with known ischemic  cardiomyopathy in my opinion were placed at great risk by this experimental protocol which I am sure would be approved in and United States university setting.

Lastly, because the experimental parameters measured were of the most fundamental and in essence primitive clinical sophistication, the conclusions of this experiment on causation of the results observed are essentially nonexistent since many different clinical scenarios can account for the observed results.  The authors so noted in their discussion some of these short fallings on their data:

However, if we take into account the experimental data obtained from animals besides the typical metabolic circumstances of kidney failure that requires dialysis, it is surprising to observe the haemodynamic pattern that is traced and which, contrary to expectations, shows a hypertensive effect for acute decrease in serum potassium. In fact, the experimental hypokalaemia model demonstrates a vasoconstriction and an increase in myocardial contractility [11-13]. The difference between the theoretical and the observed pattern could be due to the method employed to evaluate peripheral resistance (indirect, non-invasive measurements using beat-to-beat in our case) and the metabolic circumstances of dialysis with sharp variations in other factors that together can modify haemodynamics (calcaemia, osmolarity, acid-base balance, temperature), as well as concomitant counterregulatory phenomena, particularly the sympathetic and renin- angiotensin systems. The fact that hypokalaemia sensitizes myocardium to hypoxic related dysfunction [26] together with the selection for the study of an elderly population (mean age 70.3 years) with a high incidence of ischemic cardiomyopathy (10 out of 24 subjects) could have influenced the incidence of intra-dialytic hypotensions and the results. Moreover two other reasons could potentially explain a blood pressure reduction related to acute potassium decrease in the dialysis population: hypokalaemia may exacerbate autonomic dysfunction while intra-dialytic potassium loss accounts for a decrease in total osmoles [7].  

Regardless of the pathophysiological explanations of the haemodynamic consequences, the results are potentially relevant in that (i) dialysate potassium concentration could theoretically be modulable in a profile, as proposed for other electrolytes like sodium and bicarbonate and (ii) more attention could be paid to controlling the potassium balance with alternative measures (diet, chelating agents, avoidance of medications which inhibits the renin-angiotensin system if unnecessary [27] and possibly prescription of mineralocorticoids [28]). 

Thus, the authors in this ill advised and poorly executed study advance proposed clinical solutions to the resultant observations even though they have not elucidated the underlying pathophysiology of the data observed.  The ethical prohibition against experimentation that places patients at risk were not applied to this study with elderly patients, nearly half of which with known ischemic cardiomyopathy. In addition, they had no documented electrocardiographic monitory and oxygen saturation accompanied the simply blood pressure results. Nor did the authors evaluate any of these patients for regional wall motion abnormalities during the differing potassium levels.  A simple measure of cardiac enzymes could have substituted for the more expensive cardiac imaging. In addition, the authors did not comment on the measured levels of potassium in the patients. It is already known that giving a 3 K bath to dialysis patients with a potassium level higher than 5.6 is dangerous with 17% of the hypotensive episodes noted in the high potassium groups:

Prevention of Sudden Cardiac Death in Dialysis Patients: A Nephrologist's Perspective

Notably, the inappropriate use of a high-potassium dialysate (Greater than or equal to 3 mEq/L) in patients with a serum potassium greater than 5.6 mEq/L was associated with an increased risk of death.24 

I am thus confounded by the lack of effective safety measures utilized, the known high risk interventions in high risk patients with ischemic cardiomyopathy, the lack of defined pathophysiologic etiology of the data observed by virtue of only basic hemodynamic monitoring of the peripheral blood pressure alone all draws attention to how poorly designed this study truly is that also adds little to the discussion of intradialytic hypotension in dialysis patients due to variable potassium levels.

Unfortunately, hemodialysis patients benefit little from all of the experiments performed to date even when marked benefits are discovered, the American nephrology community in general chooses to simply ignore those findings such as the FHN and more frequent hemodialysis. However, evaluating this study reveals the cavalier approach that these researchers undertook in placing elderly, high cardiovascular risk patients to the known cardiovascular stressors with the not unexpected results obtained of increased intradialytic hypotension. In a word, I am appalled. The fact that this study not only survived ethical evaluation by a committee before it commenced and peer review prior to publication should cause great concern among dialysis patients due to the number of cardiovascular risks placed upon these patients with no safeguards. The most pertinent question is what if any cautions did the researchers advise these patients during the informed consent for the experiment? This is one of the most troubling experiments I have ever encountered.