Changes in Serum Bicarbonate Levels Caused by Acetate-Containing Bicarbonate-Buffered Hemodialysis Solution: An Observational Prospective Cohort Study.

Fresenius Medical Care's NaturaLyte dialysate has been associated with increased risk of sudden cardiac death by causing metabolic alkalosis from its acetate content based on retrospective data using pre-dialysis bicarbonate levels only. The study objective was to measure inter/intra-dialytic changes in serum bicarbonate and degree of alkalosis conferred by varying concentrations of NaturaLyte bicarbonate dialysate. Thirty-nine hemodialysis patients were divided into four groups based on prescribed bicarbonate dialysate concentrations; Group 1 (N = 9): 30-32 mEq/L, Group 2 (N = 5): 33-34 mEq/L, Group 3 (N = 10): 35-36 mEq/L, Group 4 (N = 15): 37-40 mEq/L. Serial (pre-dialysis, immediate post-dialysis, 2 h post-dialysis, and 68 h post-dialysis) bicarbonate levels were measured. Mean pre-dialysis serum bicarbonate levels (representing 44 h post-dialysis levels) in all four groups were not statistically different. Pre-dialysis and 68 h post-dialysis bicarbonate levels in each group were also not significantly different. However, immediate post-dialysis and 2 h post-dialysis bicarbonate levels were significantly increased in all four groups proportional to dialysate dose. There was statistically significant inter-group bicarbonate level difference (P < 0.05) except between the first and second (P = 0.43) and second and third (P = 0.07) groups in the immediate post-dialysis period. Similar results were obtained for the 2 h post-dialysis period. High bicarbonate dialysate causes large and rapid fluctuations in serum bicarbonate levels during the intra/inter-dialytic period, which returns to baseline within 44 to 68 h after dialysis. This refutes the necessity to correct pre-dialysis acidosis with high bicarbonate dialysate since rapid equilibration is likely to occur and unnecessarily exposes patients to large shifts in their acid base balance.

The medical-legal responsibilities of a dialysis unit medical director.

The specialty of Nephrology, by virtue of its relationship with the dialysis procedure, is highly vulnerable to litigation. As is the case with all nephrologists, a dialysis unit medical director is not immune to medical malpractice suits, and can be held liable for any act of perceived or potential harm to any dialysis patient, regardless of the director's level of involvement. The medical director, per the Centers for Medicare and Medicaid Services (CMS) Conditions of Participation, accepts the responsibilities, accountability, and consequent legal liabilities of the quality of the medical care provided to every dialysis patient in the unit. This review is a synopsis of lawsuits filed against medical directors of dialysis units in the past forty years. Six categories of legal actions were noted; medical malpractice, fraudulent claims, self-referral and Stark Law, discrimination, negligence, and violation of patient autonomy and dignity.