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sodium bicarbonate powder bicarbonate hemodialysis
American Healthcare
Summary: Sodium bicarbonate powder is used in hemodialysis to maintain acid-base balance. It is FDA-cleared and commonly used in dialysis settings. Key evidence highlights its role in managing electrolyte levels and potential complications like hypernatremia.
FDA Clearance Information
Pathway
510K
Number
K863631 ↗
Decision Date
October 16, 1986
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The sodium bicarbonate powder for hemodialysis by American Healthcare was cleared via the FDA 510(k) pathway on October 16, 1986. It is classified as a Class 2 device under product code KPO.
What It Is
Sodium bicarbonate powder is a dialysate component used in hemodialysis to help maintain acid-base balance in patients. It is dissolved in water to create a bicarbonate solution that aids in the removal of waste products from the blood.
Clinical Applications
This device is commonly used in hemodialysis settings to correct metabolic acidosis in patients with chronic kidney disease. It is particularly useful in dialysis centers where powdered dialysate is prepared manually.
Evidence Summary
The literature includes six studies, ranging from 1994 to 2011, encompassing various study designs such as RCTs and case series. These studies explore the efficacy and safety of sodium bicarbonate powder in dialysis.
Reported Outcomes
Published studies report that sodium bicarbonate powder is effective in maintaining acid-base balance during hemodialysis. It has been associated with improved nutritional status and reduced inflammation when used in high-purity dialysate. However, its role in immune cell modulation remains unclear.
Safety Profile
Reported complications include acute hypernatremia due to improper dissolution of the powder, as noted in one study. Other studies highlight the potential for contamination and degradation when using conventional dialysate preparations.
Evidence Limitations
The evidence is limited by the small number of studies and the variability in study designs. Further research is needed to explore long-term outcomes and the impact of high-purity dialysate on immune function.
Frequently Asked Questions
What are the clinical indications for sodium bicarbonate powder?
It is indicated for use in hemodialysis to manage metabolic acidosis in patients with chronic kidney disease.
What outcomes have been reported in clinical studies?
Studies report effective acid-base balance maintenance and potential nutritional and inflammatory benefits.
What complications have been reported?
Safety data indicate risks of hypernatremia and contamination with conventional dialysate preparations.
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.