Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors
AUDIENCE: Nephrology, Nursing
FDA is notifying health care providers to consider the presence and quantity of acetate, citrate, and/or acetic acid in dialysate concentrates when determining the patients’ dialysate prescription. The FDA received a complaint describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate. When metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis. This can contribute to metabolic alkalosis, which is a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia.
BACKGROUND: Dialysate is a solution prescribed by physicians for use in the treatment of acute and chronic renal failure during the hemodialysis procedure. The dialysate solution is used in combination with the hemodialysis machine and dialyzer to remove wastes from the blood.
Dialysate acid concentrate can contain acetic acid, acetate or citrate, and that these substances can be converted in the body to bicarbonate, potentially contributing to metabolic alkalosis. These substances typically are found in acid concentrate in amounts ranging from 1.5 to 8 mEq/L. This potential exists for all currently marketed dialysate concentrate products containing acetate, acetic acid, or citrate.
RECOMMENDATION: Health care providers should review the dialysate acid concentrate labeling for the specific concentrate that they prescribe to determine the components that can contribute to the patient's overall bicarbonate levels. The levels of acetate, citrate and/or acetic acid vary by formulation and by manufacturer. Be aware that metabolic alkalosis (pre-dialysis serum bicarbonate levels > or = to 27 mEq/L) has been associated with a higher risk of death in hemodialysis patients.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA Safety Communication, at:
FDA提醒醫療人員，在處方透析液給病人前，應考量透析液中所含acetate、citrate或acetic acid的含量。FDA接獲有關進行血液透析時，因透析液中含有acetic acid及acetate，導致給與鹼化劑量估算錯誤的通報。這些acetate、citrate或acetic acid代謝後可能會增加病人的bicarbonate level，而導致代謝性鹼中毒（metabolic alkalosis），此為心肺終止（cardiopulmonary arrest）、低血壓、低血鉀、血氧過低（hypoxemia）、高碳酸血症（hypercapnia）及心律不整的重要危險因子。
透析液是治療急性或慢性腎衰竭時，進行血液透析時所使用的溶液，需配合儀器來移除血液中的代謝廢物。透析液中可能含有acetic acid、actate或citrate，而這些鹼性物質在透析液中的可能含量範圍為1.5-8 mEq/L。
建議醫療人員在處方透析液前，須確認透析液中acetate、citrate或acetic acid含量，並警覺代謝性鹼中毒（血液透析前的血中bicarbonate level≧27 mEq/L）是血液透析病人致死的高危險因子。