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hemo-lyte hemodialysis grade sodium bicarbonate solution
Di-Chem
Summary: The hemo-lyte solution is a hemodialysis-grade sodium bicarbonate solution used primarily in dialysis. Key evidence highlights its role in managing metabolic acidosis in chronic kidney disease (CKD).
FDA Clearance Information
Pathway
510K
Number
K012547 ↗
Decision Date
January 18, 2002
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The hemo-lyte solution was cleared by the FDA via the 510(k) pathway on January 18, 2002. It is manufactured by Di-Chem and classified as a Class 2 device.
What It Is
The hemo-lyte solution is a sodium bicarbonate solution used in hemodialysis to help manage metabolic acidosis in patients with chronic kidney disease. It is designed to restore bicarbonate levels during dialysis sessions.
Clinical Applications
This solution is commonly used in dialysis settings to correct metabolic acidosis in patients with CKD. It is particularly relevant for patients experiencing low bicarbonate levels during dialysis.
Evidence Summary
The literature includes 9 studies, comprising various study types such as RCTs and prospective trials, conducted between 2016 and 2022. These studies explore the efficacy and safety of sodium bicarbonate in CKD management.
Reported Outcomes
Published studies report that sodium bicarbonate therapy can improve metabolic acidosis in CKD patients. Some studies suggest potential benefits in slowing CKD progression and improving quality of life, though evidence is mixed.
Safety Profile
Reported complications include potential risks of worsening hypertension and fluid overload, particularly in older patients with advanced CKD. These safety concerns highlight the need for careful patient monitoring.
Evidence Limitations
Current evidence is limited by small sample sizes and variability in study designs. Further research is needed to establish definitive efficacy and safety profiles, particularly in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for hemo-lyte hemodialysis grade sodium bicarbonate solution?
The solution is indicated for correcting metabolic acidosis in patients undergoing hemodialysis, particularly those with chronic kidney disease.
What outcomes have been reported in clinical studies?
Studies report improvements in metabolic acidosis and potential benefits in CKD progression and quality of life, though results are mixed.
What complications have been reported?
Safety data indicate risks of worsening hypertension and fluid overload, 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.