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Heat Disinfection of HD Water Treatment System in Hemodialysis Patients

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier:
NCT01138280
First received: May 25, 2010
Last updated: June 4, 2010
Last verified: January 2005
History of Changes
  Purpose

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.


Condition Intervention Phase
All Cause Mortality
 Device: CWP 103H (Gambro, Sweden): a heat disinfection device
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Heat Disinfection of HD Water Treatment System on Cardiovascular Events and Outcome in Hemodialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taipei Veterans General Hospital,Taiwan:

Primary Outcome Measures:
  • CV events, CV [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • all-cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • biofilm formation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • endotoxin level of dialysis water [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • pro-inflammatory cytokine levels in serum [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 540
Study Start Date: March 2005
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Heat disinfection
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
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 Names:
  • Heat disinfection (temperature up to 95 c)
  • RO water treatment system
  • piping system
  • dialysis machine
No Intervention: Conventional RO water treatment
Placebo arm: conventional chemical disinfection link to RO water treatment system.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138280

Locations
Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
Taipei Veterans General Hospital,Taiwan
National Science Council, Taiwan
Investigators
Principal Investigator: Der-Cherng Tarng, MD, PhD Taipei Veterans General Hospital,Taiwan
  More Information

No publications provided

Responsible Party: DER-CHERNG TARNG, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT01138280     History of Changes
Other Study ID Numbers: VGHIRB 96-12-21A, VGHUST97-P1-01
Study First Received: May 25, 2010
Last Updated: June 4, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taipei Veterans General Hospital,Taiwan:
biofilm formation
proinflammatory cytokines
high sensitive c reactive protein
 cardiovascular events
overall mortality
hemodialysis

ClinicalTrials.gov processed this record on May 19, 2013