Background Information for the Fresenius Medical Care Memos (2011-2012) concerning Alkalosis, Patient Safety and Granuflo® Use

(last edited Sept. 29, 2013)

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FDA Documents:
Public Information from Fresenius Medical Care:
RenalWEB Articles on the Fresenius Medical Care (FMC) Memos Concerning Alkalosis, Patient Safety and Granuflo® Use:
  Correction to Part I:

The Granuflo product began with the product name "Granulyte." The 510(K) was submitted by Fresenius USA in April 1992 and it received "clearance" in March 1994. The trademark for Granuflo was granted in September 1994. In 2003, FMC received a 510(k) for a non-granulated formulation of Granuflo. RenalWEB misreported that Granuflo received its first 510(k) in 2003.

(The use of Granuflo and other dry chemical mixing systems gained widespread use after 2003 when oil prices and transportation costs began steadily increasing. It appears that Granulyte contained sodium diacetate from the product's inception.)
Related Articles:
Fresenius Medical Care Memos on Alkalosis, Patient Safety, and Granuflo Use:
  • Nov. 4, 2011 Internal FMC Memo (6-page pdf). This was first published publicly on The New York Times web site (see here) on June 14, 2012.

  • March 29, 2012 External FMC Memo (2-page pdf)
Medical References Provided by Fresenius Medical Care and the FDA:
       From the Nov. 4, 2011 Internal FMC Memo:
(1) Mitch WE, Jurkovitz C, England BK. Mechanisms that cause protein and amino acid catabolism in uremia. Am J Kidney Dis 1993;21:91-95.

(2) Bailey JL, Mitch WE. Metabolic acidosis as a uremic toxin. Semin Nephrol 1996; 16:160-166.

(3) Movilli E, Zani R, Carli 0 et al. Direct effect of the correction of acidosis on plasma parathyroid hormone concentrations, calcium and phosphate in hemodialysis patients: a prospective study. Nephron 2001 ;87:257 -262.

(4) Williams AJ, Dittmer ID, McArley A, Clarke J. High bicarbonate dialysate in haemodialysis patients: effects on acidosis and nutritional status (full-text pdf). Nephrol Dial Transplant 1997; 12:2633-2637.

(5) National Kidney Foundation. Clinical practice guidelines for nutrition in chronic renal failure. K/DOQI, National Kidney Foundation (table of contents). Am J Kidney Dis 2000;35:S1-140.

(6) Bommer J, Locatelli F, Satayathum S et al. Association of predialysis serum bicarbonate levels with risk of mortality and hospitalization in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 2004;44:661-671.

(7) Heguilen RM, Sciurano C, Bellusci AD et al. The faster potassium-lowering effect of high dialysate bicarbonate concentrations in chronic haemodialysis patients (full-text). Nephrol Dial Transplant 2005;20:591-597.

(8) Karnik JA, Young BS, Lew NL et al. Cardiac arrest and sudden death in dialysis units (full text). Kidney lnt 2001 ;60:350-357.

(9) Bleyer AJ, Hartman J, Brannon PC, Reeves-Daniel A, Satko SG, Russell G. Characteristics of sudden death in hemodialysis patients (full text). Kidney lnt 2006;69:2268- 2273.

(10) Fresenius Medical Care. Serum Bicarbonate levels. Medical Staff Newsletter. January, 2010

       From the March 29, 2012 External FMC Memo (2-page pdf):
(1) Gennari FJ. Very low and high predialysis serum bicarbonate levels are risk factors for mortality: What are the Appropriate Interventions? Semin Dial, May-June;23(3):253-257 2010

(2) Wu DY, Shinaberger CS, Regidor DL, McAllister CJ, Kopple JD, Kalantar-Zadeh K: Association between serum bicarbonate and death in hemodialysis patients: is it better to be acidotic or alkalotic? Clin J Am Soc Nephrol 1:70-78, 2006

(3) Bommer J, Locatelli F, Satayathum S, Keen, MI Goodkin DA, Saito A, Akiba T, Port FK, Young EW: Association of predialysis serum bicarbonate levels with risk of mortality and hospitalization in the dialysis outcomes and practice pattern study (DOPPS). Am J Kidney Dis 44:661-671 2004

(4) Lowrie EG, Lew NL: Death risk in hemodialysis patients: the predictive value of commonly measured variables and an evaluation of death rate differences between facilities. Am J Kidney Dis 15:458-482, 1990

       From the FDA's May 25th, 2012 Safety Communication:
A recent report from the National Kidney Foundation 2011 Spring Clinical Meetings retrospectively evaluated 50 hemodialysis patients hospitalized in October 2010. Their outpatient dialysate prescription included a 35 mEq/L bicarbonate solution and an acid concentrate which contained 8 mEq/L of acetate (total bicarbonate of 43 mEq/L). At presentation, the patients’ mean serum bicarbonate level was 31.3 mEq/L and 54 percent had a serum bicarbonate >30 mEq/L. (Pande S, Raja R, Bloom E, Chewaproug D, Dissanayake I. Effect of dialysate baths on serum bicarbonate levels in hemodialysis patients. American Journal of Kidney Disease 2011; 57(4): A75 (Abstract #234)) (journal subscription or payment is required to view)

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