Filtration fluid for hemodialysis treatment

Area of Science:

• Nephrology
• Biomedical Engineering
• Infectious Disease Control

Background:

• Bacterial contamination in dialysis fluid poses significant risks, leading to cytokine release and adverse effects in patients undergoing renal replacement therapy.
• Ensuring sterile, endotoxin-free dialysis fluid is crucial for patient safety and treatment efficacy.
• Previous attempts to eliminate pyrogenic substances highlight the ongoing need for advanced filtration technologies.

Purpose of the Study:

• To evaluate the efficacy and long-term performance of the DIASAFE dialysis fluid filter in removing microorganisms and endotoxins.
• To assess the filter's stability and microbiological functionality under clinical conditions for an extended period.
• To investigate the filter's impact on beta2-microglobulin levels in patients undergoing hemodialysis.

Main Methods:

• The DIASAFE filter, featuring a Polysulfone membrane, was tested for 1,000 hours (approximately 14 weeks).
• Dialysis fluid samples were collected weekly, before and after the filter, for microbial and endotoxin analysis.
• Serum samples were analyzed for beta2-microglobulin concentration starting from the fourth week of the study.

Main Results:

• The filter demonstrated a significant reduction in microorganisms, achieving at least a 10^5 reduction and often exceeding 10^6 in 86% of samples.
• Microbiological functionality and filter stability were confirmed for over 1,000 hours and 150 disinfecting cycles under clinical conditions.
• Effective endotoxin reduction was observed, with concentrations dropping below 0.1 IU/ml from initial levels exceeding 0.5 IU/ml.
• A trend towards reduced beta2-microglobulin levels in patient serum was noted, decreasing from 32.5+/-3.9 mg/L to 21.5+/-5.3 mg/L.

Conclusions:

• The DIASAFE dialysis fluid filter is highly effective in reducing bacterial contaminants and endotoxins in dialysis fluid.
• The filter provides crucial protection for patients undergoing renal replacement therapy against acute and chronic complications.
• The study confirms the filter's stability and microbiological efficacy for extended use in clinical settings, ensuring patient safety.