Heat Disinfection of HD Water Treatment System in Hemodialysis Patients

NCT01138280 | Completed Phase 4 DMC

• 2 other identifiers: VGHIRB 96-12-21AVGHUST97-P1-01
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

All Cause Mortality

Keywords

biofilm formation; proinflammatory cytokines; high sensitive c reactive protein; cardiovascular events; overall mortality; hemodialysis

Outcome Measures

Primary Outcomes (2)

• CV events, CV

  5 years

• all-cause mortality

  5 years

Secondary Outcomes (3)

• biofilm formation

  5 years

• endotoxin level of dialysis water

  5 years

• pro-inflammatory cytokine levels in serum

  5 years

Study Arms (2)

Heat disinfection

EXPERIMENTAL

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

Conventional RO water treatment

NO INTERVENTION

Placebo arm: conventional chemical disinfection link to RO water treatment system.

Interventions

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

Also known as: Heat disinfection (temperature up to 95 c), RO water treatment system, piping system, dialysis machine

Heat disinfection

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 20 years and duration of HD over 3 months, and clinically stable

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Interventions

Kidneys, Artificial

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies

Study Officials

• Der-Cherng Tarng, MD, PhD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 25, 2010
• First Posted: June 7, 2010
• Study Start: March 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: June 7, 2010

Record last verified: 2005-01

Locations

TW (1)