A Phase 4 interventional study of CWP 103H (Gambro, Sweden): a heat disinfection device in All Cause Mortality, sponsored by Taipei Veterans General Hospital, Taiwan. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-06-07.
Sponsored by Taipei Veterans General Hospital, Taiwan · Phase 4, Interventional, and Treatment
Hemodialysis (HD) may lead to increase inflammatory response through a number of mechanisms. HD-related inflammation is mainly due to underlying kidney disease, coexisting comorbidities, uremia per se, dialyzer membrane biocompatibility and contaminated dialysis fluid. Accordingly, HD patients are chronically exposed to microinflammation as a result of blood-membrane interaction and dialysis fluid contamination. Among these factors, biofilm formation and contaminated dialysis fluid are closely related to enhanced immune activation in HD patients. Furthermore, only dialysis fluid quality is controllable and preventable. Therefore, to reduce the cardiovascular (CV) events and improve the outcome, it prompts us to conduct a prospective randomized controlled study to explore whether heat disinfection link in HD water treatment system can effectively prevent biofilm formation, to ensure the dialysis fluid purity, and subsequently to improve the patient outcome, in terms of CV events and mortality.
Inflammation is common in individuals with both chronic kidney disease (CKD) and hemodialysis (HD). HD may lead to increased inflammatory response through a number of mechanisms; some of these factors also result in pro-inflammatory cytokine release and consequently cause the overlap between anemia, accelerated atherosclerosis and inflammation. HD-related inflammation is mainly due to underlying kidney disease, coexisting comorbidities, uremia per se, dialyzer membrane biocompatibility and contaminated dialysis fluid. Accordingly, HD patients are chronically exposed to microinflammation as a result of blood-membrane interaction and dialysis fluid contamination. Among these factors, biofilm formation and contaminated dialysis fluid are closely related to enhanced immune activation in HD patients. Furthermore, only dialysis fluid quality is controllable and preventable. Therefore, to correct rHuEPO poor response and reduce the cardiovascular (CV) events, it prompts us to conduct a prospective randomized controlled study to explore as to whether heat disinfection link in HD water treatment system can effectively prevent biofilm formation, to ensure the dialysis fluid purity, and subsequently to improve the patient outcome, in terms of CV events and mortality.
Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.
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Experimental arm: Heat disinfection link to RO water treatment system and piping system to dialysis machine
Device: CWP 103H (Gambro, Sweden): a heat disinfection device
Placebo arm: conventional chemical disinfection link to RO water treatment system.
Heat disinfection can increase temperature to 95c in the RO water treatment system and then in the piping system link to dialysis machines in each hemodialysis center per night
Also known as: Heat disinfection (temperature up to 95 c), RO water treatment system, piping system, dialysis machine
CV events, CV
Time frame: 5 years
all-cause mortality
Time frame: 5 years
biofilm formation
Time frame: 5 years
endotoxin level of dialysis water
Time frame: 5 years
pro-inflammatory cytokine levels in serum
Time frame: 5 years
This study is completed, as verified in Jan 2005. You cannot join it, but the record below documents what was studied.
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Taipei Veterans General Hospital, Taiwan