GranuFlo and NaturaLyte Withdrawal

Granuflo and NaturaLyte are products made by Fresenius, as buffer solutions in the final dialysis solution. Buffers control the pH of the solution and blood. There is concern that incorrectly mixed dialysate could lead to problems for dialysis patients.

Both products are an acetic acid / sodium acetate mixture. Buffers are a mixture of a weak acid and its sodium salt, and the choice of acid and salt determine the pH range over which the buffer will operate.

The first problem is that the body can metabolize acetate ions to carbonate and hydrogencarbonate (bicarbonate) ions, thus raising the level of bicarbonate in the blood. And bicarbonate ions are are part of one of the body's own buffer control systems. Altering the bicarbonate levels can lead to a pH imbalance and metabolic alkalosis - the blood is too alkaline during and after dialysis.

And metabolic alkalosis is an independent risk factor for low blood pressure, low blood oxygen, high blood carbon dioxide, heart rhythm problems, and sudden cardiac death.

Now the second problem.

A leaked memo from Fresenius was made available to the FDA. In it, Fresenius warned doctors at its company-owned clinics of the risk of GranuFlo side effects when using these concentrates. It advised its doctors to check bicarbonate levels in patients before dialysis, and to adjust prescriptions as necessary. The company failed, however, to warn outside clinics of the risks associated with GranuFlo and NaturaLyte.

Eventually the FDA issued a class 1 recall on these two products.

One interesting result I found was this article, dated 2009, claiming that acetate buffers are an old-fashioned type of buffer and, on my reading of it, had been replaced. So why were Fresenius still producing these products at all? Well, neither product is dangerous in it's own right, it is the risk of errors when making up the final solutions to administer to patients that is the problem.

Other acid concentrates are primarily just acetic acid. As a PhD chemist I have to point out that the acetic acid in these concentrates will interact with any sodium in the blood to result in sodium acetate being present in solution. Thus the acetate ions are present once again and metabolism to bicarbonate will still occur. Presumably the amount of acetate ions will be so much lower in these cases that the conversion will be much less of a problem.

Problems when patients start dialysis too soon.

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 recently, the number of elderly people (those 75 and over) who started dialysis when their GFR was lower than 10 increased from 1 in 4 (in 1996) to more than 6 in 10 (in 2009), according to an article at The Journal of the American Medical Association.

It is suggested that with medics receiving a referral fee from dialysis centres, patients were being referred sooner than necessary. Whether or not this is a factor, the article says that early introduction to dialysis is not justified. Elderly patients with age related decreases in muscle mass may have higher GFR due to this problem instead. And being subjected to dialysis can lead to a higher risk of death, while a controlled trial found no benefit from starting dialysis early. Indeed the article stated that for those over 80, they were more likely to die from other causes before starting dialysis.

The article ends with the following statement:
"The public perception that pursuit of dialysis is always in patients' best interest should be replaced by a more realistic view of the “sad truth” about early dialysis initiation in elderly patients."

Dialysis demand increases after elective surgery

Elective surgery - surgery which can be scheduled in advance as it does not involve a medical emergency.

The number of patients needing dialysis after major elective surgery has tripled since 1995, a Canadian study reported here suggests.

Researchers reviewed data on 552,672 patients in Ontario who had elective major surgery in the province between 1995 to 2009. Out of this group, 2,231 received acute dialysis within 14 days after surgery. This represents an increase from 0.2 percent in 1995 to 0.6 percent in 2009. An extra 0.4 percent might not seem much, but it's 1487 more people!

According to kidney specialist Dr. Amit Garg of London Health Sciences Centre, when someone develops the complication and is sick enough after surgery to need dialysis, 40 per cent will unfortunately have died at 90 days. So it's a very high risk of death in patients who develop this complication. And in those who survive 90 days, one fourth are now left with permanent kidney failure needing ongoing maintenance dialysis and those outcomes haven't changed in the last 15 years.

Older, sicker patients may be higher risk of acute kidney injury, the researchers said, with people who already had weak kidneys, or high blood pressure or diabetes before the surgery at highest risk.

Kidney Donor Refused Insurance

One of the first things that is checked after a matching donor is found is that they are in good health. Very good health. So when Radburn Royer donated a kidney to his daughter, Erika, he was glad to be told he was in great shape.

But when he tried to get medical insurance and life insurance, he was told he had chronic kidney disease as he only had one kidney. The refusal has stunned him. As a donor he had to be in great shape to be accepted, but two insurance companies are saying otherwise.

There is little data on how often kidney donors have trouble obtaining insurance, but advocates say the fear of being uninsurable may be a powerful deterrent to donation. A 2006 study done by an advocacy organization for transplant professionals found that 39 percent of transplant centers reported that they had had eligible donors who declined to donate because they feared having future insurance problems. Being treated like this could potentially affect thousands of people (especially those with family of their own who would like to think they would be looked after if anything went wrong).

This article mentions several others who faced similar treatment when seaking various types of insurance. Other donors faced problems at work if they needed more time to recover than expected. This sort of thing will not encourage potential donors

Hope for Kidney Regeneration

Indiana University School of Medicine scientists have successfully transplanted primary kidney cells intravenously to treat renal failure in rats, pointing the way to a possible future alternative to kidney transplants and expensive dialysis treatments in humans.

The researchers (above), Katherine J. Kelly, M.D., associate professor of medicine, and Jesus Dominguez, M.D., professor of medicine, genetically modified the cells in the laboratory to produce a protein – called SAA – that plays an important role in renal cell growth, embryonic kidney development and kidney regeneration after an injury. Modified cells found their way to the appropriate locations of the damaged kidneys, resulting in regeneration of tissue and improved function in the kidney.

"Ultimately, you can imagine taking a part of someone's kidney, expanding those cells with appropriate growth factors in a tissue culture dish, and then giving the cells back," said Dr. Kelly.

The researchers cautioned, however, that much work remains to be done before tests could begin in humans.

Their work will be published in an article in American Journal of Physiology – Renal Physiology, read the abstract