All Cause Mortality
Conditions
Keywords
biofilm formation, proinflammatory cytokines, high sensitive c reactive protein, cardiovascular events, overall mortality, hemodialysis
Brief summary
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.
Detailed description
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.
Interventions
DEVICECWP 103H (Gambro, Sweden): a heat disinfection device
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
Sponsors
National Science and Technology Council, Taiwan
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age over 20 years and duration of HD over 3 months, and clinically stable
Exclusion criteria
* patients with acute infection, malignancy, active autoimmune disease, GI bleeding or blood loss; systemic inflammatory disease; life expectancy less than 3 months, and unwilling to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CV events, CV | 5 years |
| all-cause mortality | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| biofilm formation | 5 years |
| endotoxin level of dialysis water | 5 years |
| pro-inflammatory cytokine levels in serum | 5 years |
Countries
Taiwan
Outcome results
None listed