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hemodialysis bath concentrate solution
Pharmaceutical Development Systems
Summary: The hemodialysis bath concentrate solution is used in dialysis to maintain acid-base balance. Key evidence highlights its impact on acid-base homeostasis and potential complications.
FDA Clearance Information
Pathway
510K
Number
K842058 ↗
Decision Date
July 26, 1984
Product Code
FKQ
Device Class
Class 2
Evidence
0 studies
The hemodialysis bath concentrate solution was cleared via the FDA 510(k) pathway on July 26, 1984. It is manufactured by Pharmaceutical Development Systems and classified as a Class 2 device.
What It Is
The hemodialysis bath concentrate solution is a medical device used in hemodialysis to help maintain the patient's acid-base balance by providing necessary electrolytes and bicarbonate. It is intended for use in patients undergoing dialysis treatment.
Clinical Applications
This device is commonly used in clinical settings for patients with renal failure requiring hemodialysis. It is particularly important for managing acid-base disturbances during dialysis sessions.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and retrospective analyses, with publication dates ranging from 2020 to 2024.
Reported Outcomes
Published studies report that the hemodialysis bath concentrate solution effectively manages acid-base balance during dialysis. It has been shown to influence bicarbonate and CO2 levels, impacting overall metabolic acidosis and alkalosis management.
Safety Profile
Reported complications include unexpected occurrences of respiratory alkalosis and acidosis during treatment. The studies highlight the need for careful monitoring of acid-base homeostasis in patients using this solution.
Evidence Limitations
The evidence is limited by the small sample sizes and the variability in study designs. Further research is needed to explore long-term outcomes and optimize dialysate composition for different patient populations.
Frequently Asked Questions
What are the clinical indications for hemodialysis bath concentrate solution?
The clinical indications include use in hemodialysis to manage acid-base balance in patients with renal failure.
What outcomes have been reported in clinical studies?
Studies have reported effective management of acid-base balance, with impacts on bicarbonate and CO2 levels during dialysis.
What complications have been reported?
Safety data indicate occurrences of respiratory alkalosis and acidosis, necessitating careful monitoring during use.
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.