Status:
COMPLETED
Efficacy and Safety of Ethanol Lock Solution in Prevention of Catheter Related Bloodstream Infection for Patients Suffering Acute Renal Failure, and Hospitalized in Intensive Care Unit. A Multi-Center, Randomized, Versus Placebo, Double Blinded Clinical Trial
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Acute Renal Failure
Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients.
Detailed Description
The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients
Eligibility Criteria
Inclusion
- Patients of both genders, over 18 years,
- Patients admitted in ICU
- Dialysis catheter insertion for renal replacement therapy
- At least two renal replacement therapy sessions
- Written informed consent
- Social security
Exclusion
- Pregnant or breastfeeding women
- Patient requiring dialysis on arteriovenous fistula or permanent catheter
- Known allergy to ethanol
- Dialysis catheter covered or impregnated with antimicrobial agent
- Dialysis catheter insertion before ICU admission
- Single-lumen dialysis catheters
- Patient whose death is likely to occur within hours after admission to ICU
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
1460 Patients enrolled
Trial Details
Trial ID
NCT00875069
Start Date
April 1 2009
End Date
February 1 2013
Last Update
June 16 2014
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003