Heat Disinfection of HD Water Treatment System in Hemodialysis Patients

Taipei Veterans General Hospital

Status and phase

Completed

Phase 4

Conditions

All Cause Mortality

Treatments

Device: CWP 103H (Gambro, Sweden): a heat disinfection device

Study type

Interventional

Funder types

Other

Identifiers

NCT01138280

VGHUST97-P1-01 (Other Grant/Funding Number)

VGHIRB 96-12-21A

Details and patient eligibility

About

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.

Full 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.

Enrollment

540 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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.