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hemo-lyte hemodialysis grade sodium bicarbonate powder
Di-Chem
Summary: The hemo-lyte hemodialysis grade sodium bicarbonate powder by Di-Chem is used in dialysis to manage metabolic acidosis in chronic kidney disease. Key evidence suggests its role in modifying disease progression and managing acidosis.
FDA Clearance Information
Pathway
510K
Number
K012328 ↗
Decision Date
January 18, 2002
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The hemo-lyte powder was cleared via the FDA 510(k) pathway on January 18, 2002. Manufactured by Di-Chem, it is classified as a Class 2 device under product code KPO.
What It Is
The hemo-lyte hemodialysis grade sodium bicarbonate powder is a medical-grade bicarbonate used in dialysis to correct metabolic acidosis in patients with chronic kidney disease. It is intended for use in hemodialysis treatment settings.
Clinical Applications
Commonly used in dialysis centers, this device is applied in the management of metabolic acidosis in patients with chronic kidney disease, particularly during hemodialysis sessions to maintain acid-base balance.
Evidence Summary
The available literature includes 9 studies, comprising randomized controlled trials and prospective studies, published between 2016 and 2022. These studies evaluate the efficacy and safety of sodium bicarbonate in managing chronic kidney disease.
Reported Outcomes
Published studies report that sodium bicarbonate therapy may slow the progression of chronic kidney disease and improve metabolic acidosis. Some studies suggest potential benefits in cardiovascular health and physical function, although results are mixed.
Safety Profile
Reported complications include potential risks of worsening hypertension and fluid overload, particularly in patients with advanced chronic kidney disease. Safety profiles vary across studies, highlighting the need for individualized patient assessment.
Evidence Limitations
Evidence gaps exist in long-term outcomes and the impact of sodium bicarbonate on cardiovascular health. Further research is needed to establish optimal dosing and to confirm findings across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for hemo-lyte hemodialysis grade sodium bicarbonate powder?
The device is indicated for correcting metabolic acidosis in patients undergoing hemodialysis due to chronic kidney disease.
What outcomes have been reported in clinical studies?
Studies report potential benefits in slowing CKD progression and improving metabolic acidosis, with mixed results on cardiovascular and physical function outcomes.
What complications have been reported?
Reported complications include risks of hypertension and fluid overload, necessitating careful patient monitoring.
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.