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Completed

NCT Number: NCT01138280

Heat Disinfection of HD Water Treatment System 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.

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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. CV events, CV

    Time frame: 5 years

  2. all-cause mortality

    Time frame: 5 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Jun 7, 2010
Registry last updated
Jun 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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