Heat Disinfection of HD Water Treatment System in Hemodialysis Patients

June 4, 2010 updated by: Taipei Veterans General Hospital, Taiwan

Effect of Heat Disinfection of HD Water Treatment System on Cardiovascular Events and Outcome in Hemodialysis Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

540

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CV events, CV
Time Frame: 5 years
5 years
all-cause mortality
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
biofilm formation
Time Frame: 5 years
5 years
endotoxin level of dialysis water
Time Frame: 5 years
5 years
pro-inflammatory cytokine levels in serum
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Collaborators

National Science Council, Taiwan

Investigators

  • Principal Investigator: Der-Cherng Tarng, MD, PhD, Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

May 25, 2010

First Submitted That Met QC Criteria

June 4, 2010

First Posted (Estimate)

June 7, 2010

Study Record Updates

Last Update Posted (Estimate)

June 7, 2010

Last Update Submitted That Met QC Criteria

June 4, 2010

Last Verified

January 1, 2005

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VGHIRB 96-12-21A
  • VGHUST97-P1-01 (Other Grant/Funding Number: Taipei Veterans General Hospital, Taiwan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on All Cause Mortality

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe