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Heat Disinfection of HD Water Treatment System in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT01138280
Recruitment Status : Completed
First Posted : June 7, 2010
Last Update Posted : June 7, 2010
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
Taipei Veterans General Hospital, Taiwan

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Heat Disinfection of HD Water Treatment System on Cardiovascular Events and Outcome in Hemodialysis Patients
Study Start Date : March 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. CV events, CV [ Time Frame: 5 years ]
  2. all-cause mortality [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. biofilm formation [ Time Frame: 5 years ]
  2. endotoxin level of dialysis water [ Time Frame: 5 years ]
  3. pro-inflammatory cytokine levels in serum [ Time Frame: 5 years ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Grant/Funding Number: Taipei Veterans General Hospital, Taiwan )
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: June 7, 2010
Last Verified: January 2005

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