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hemodialysis concentrate formulations additives
Physicians Surgeons Purchasing Group
Summary: Hemodialysis concentrate formulations additives are used in dialysis to manage electrolyte balance. Key evidence highlights the role of citrate dialysates in maintaining stable iPTH levels and preventing hypomagnesemia with supplementation.
FDA Clearance Information
Pathway
510K
Number
K860296 ↗
Decision Date
March 4, 1986
Product Code
FKQ
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on March 4, 1986, by Physicians Surgeons Purchasing Group. It is classified as a Class 2 device under product code FKQ.
What It Is
Hemodialysis concentrate formulations additives are used to prepare dialysate solutions for hemodialysis, which help in maintaining electrolyte and acid-base balance in patients undergoing dialysis. These formulations are critical in managing chronic kidney disease and associated metabolic complications.
Clinical Applications
These additives are commonly used in clinical settings for patients with end-stage renal disease undergoing hemodialysis. They are essential in scenarios where precise electrolyte management is required to prevent complications such as metabolic acidosis or electrolyte imbalances.
Evidence Summary
The available literature includes 10 studies, with study types ranging from prospective to retrospective analyses. The studies span from 2021 to 2025, providing insights into the efficacy and safety of different dialysate formulations.
Reported Outcomes
Published studies report that citrate dialysates can maintain stable iPTH levels and reduce post-dialysis total calcium. Additionally, the use of magnesium supplementation with citrate dialysates prevents hypomagnesemia. These outcomes suggest potential benefits over traditional acetate dialysates.
Safety Profile
Reported complications include no significant increase in adverse events when using citrate dialysates compared to acetate. The safety profile is generally favorable, with magnesium supplementation mitigating risks of hypomagnesemia.
Evidence Limitations
The evidence is limited by the variability in study designs and the relatively small sample sizes in some studies. Further research is needed to explore long-term outcomes and the impact of different formulations on patient quality of life.
Frequently Asked Questions
What are the clinical indications for hemodialysis concentrate formulations additives?
These additives are indicated for use in hemodialysis to manage electrolyte and acid-base balance in patients with chronic kidney disease.
What outcomes have been reported in clinical studies?
Studies have reported stable iPTH levels, reduced post-dialysis calcium, and prevention of hypomagnesemia with magnesium supplementation.
What complications have been reported?
Safety data indicate no significant increase in adverse events with citrate dialysates, and hypomagnesemia is prevented with magnesium supplementation.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.