Filtration fluid for hemodialysis treatment
V Ikonomov1, G Haase, I Stefanidis
1Medizinische Klinik II, Aachen, Germany. ikonomov@mail.vega.bg
Abstract:
Bacterial contamination of dialysis fluid has long been recognized as a problem in hemodialyis. Cytokines released as a consequence of contaminated dialysis fluid are believed to be responsible for many acute and chronic side effects in patients undergoing renal replacement therapy. For several years now, attempts have been made to eliminate pyrogenic substances and ensure a sterile and endotoxin-free dialysis fluid. A recent dialysis fluid filter known as DIASAFE, containing a membrane based on Polysulfone (Fresenius), was tested for a period of 1,000 hours (approx. 14 weeks). Dialysis fluid samples were collected once weekly before and behind the filter and cultivated for detection of microorganisms and endotoxins. Additionally, starting after the fourth week of the study, serum samples were collected weekly and the beta2-microglobulin concentration was determined. The filter reduced microorganisms at a rate of at least 10(5) and in the majority of cases (86% of samples) by more than 106. Under clinical conditions the stability and microbiological functionality of the filters could be demonstrated for more than 1,000 hours and 150 disinfecting cycles. In four cases of endotoxin burden (> 0.5 IU/ml) in the dialysis fluid in front of the filter the concentration behind the filter was lower than 0.1 IU/ml, indicating effective reduction of endotoxins. A tendency to a reduction of beta2-microglobulin in serum from 32.5+/-3.9 mg/L to 21.5+/-5.3 mg/L was observed. These results indicate that the dialysis fluid filter used was effective, dramatically reducing the bacterial contaminants in dialysis fluid, thus protecting patients from the potentially harmful acute and long-term life-threatening consequences of contaminated dialysis fluid.
Insights
A new dialysis fluid filter effectively removed bacteria and endotoxins, safeguarding patients undergoing renal replacement therapy from harmful side effects. This study confirms its long-term stability and microbiological functionality in clinical settings.
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.
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