Heat Disinfection of HD Water Treatment System in Hemodialysis Patients
Condition: All Cause Mortality
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): CWP 103H (Gambro, Sweden): a heat disinfection device
Intervention type(s): Device
Intervention description(s): 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
Other intervention name(s): Heat disinfection (temperature up to 95 c); RO water treatment system; piping system; dialysis machine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: biofilm formation; proinflammatory cytokines; high sensitive c reactive protein; cardiovascular events; overall mortality; hemodialysis