Problems with Kidney Dialysis Put Patients at Risk

For people whose kidneys no longer function well enough to process waste products or maintain proper levels of certain chemicals in the bloodstream, kidney dialysis is the only treatment except for transplant. But kidneys — and the dialysis procedure — are complicated, and a few recent stories are a heads-up for people affected by kidney failure or disease.

A patient in dialysis is hooked up to a machine that replaces the body’s natural filtration system, removing waste and excess fluid and maintaining chemical balance. Beginning this treatment too early in the disease process is not a good idea. As discussed in John James’ Patient Safety newsletter, participants in the Consumer Union Safe Patient Project are wary of the growing commercial takeover of dialysis facilities in part because of the rush to treat. “The truth,” James writes, “is that many patients have already suffered because they were steered into dialysis far too early.”

The danger is especially acute for patients older than 75. The glomerular filtration rate (GFR) quantifies the rate at which filtered fluids are processed by the kidneys. By medical consensus, a GFR of 10 is deemed “early” for dialysis. But from 1996 to 2009, the number of elderly people who started dialysis when their GFR was lower than 10 increased from 1 in 4 to more than 6 in 10.

Patients with GFRs below 20, as noted in a commentary in the Journal of the American Medical Association (JAMA), often are referred to kidney specialists, who often have financial incentives to prescribe dialysis. This is a recipe for conflict of interest, not to mention overtreatment and its adverse outcomes.

Premature kidney dialysis puts the patient at risk for life-threatening infections and even sudden death. As the JAMA article said, “Many patients with advanced chronic kidney disease have stable renal function for years and their rate of decline of renal function may vary inversely with age.” That means that the rate of kidney function decline in older people might be lower than the rate in younger people.

More bad news in kidney dialysis was depicted in the New York Times and in the Bangor Daily News. The Times recounted an FDA investigation over concerns that one national operator of dialysis centers failed to inform patients of a potentially lethal problem in one of its dialysis products. The story from Maine concerned a dialysis patient-turned-whistleblower who was tossed out of treatment when the center didn’t care for his complaints about shoddy care.

About 400,000 people in the U.S. are on kidney dialysis, and, according to The Times, Fresenius Medical Care treats more than 1 in 3 of them. It’s also the leading supplier of dialysis machines and disposable products to other operators.

Although Fresenius informed doctors practicing at its dialysis centers that failure to use GranuFlo properly seemed to be contributing to a marked increase of patient deaths from cardiac arrest, the company was tardy in warning other centers that used the concentrate. The FDA found out when someone leaked the internal memo.

The immoral, if not illegal, corporate behavior was reported first by RenalWEB, a neutral, nonaffiliated website for the dialysis industry and community. The site estimated that 125,000 patients in non-Fresenius clinics are treated with GranuFlo.

Dialysis involves bicarbonate, which neutralizes acid that builds up in the blood. GranuFlo contains more than similar products of a component the body converts into bicarbonate. Too much, however, appears to present heart problems. Doctors, apparently have not been accounting for the overdose potential GranuFlo presents.

The FDA issued an alert about GranuFlo and similar products, and dialysis centers now must check patient bicarbonate levels.

As quoted in the The Times, Dr. Daniel Coyne, director of hemodialysis at Washington University in St. Louis, said nearly 1 in 3 of its patients had elevated bicarbonate levels. “A four- to sixfold increased risk of in-center cardiac arrest is very concerning. My partners are all trying to figure out a fix to this problem.”

Kidney dialysis, it seems, is fraught with peril for patients who need or one day might need this life-saving procedure. If this describes you or a loved one, know your GFR levels, find out who owns and operates the dialysis facility you use or might use, and have a frank discussion with your doctor about age-appropriate treatment.

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