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

Phase 3

Completed

• Conditions: Infection; Acute Renal Failure
• Interventions: Other: Ethanol

• Registration Number: NCT00875069
• Lead Sponsor: University Hospital, Clermont-Ferrand

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

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Primary Completion: 2011-06
• Study Completion: 2013-02
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-13
• Last Update Posted: 2014-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1460

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ethanol	Ethanol	-
placebo	Ethanol	-

Primary Outcome Measures

Name	Time	Method
The number of major catheter-related infections (CRI) defined as either catheter-related clinical sepsis without bloodstream infection or catheter-related bloodstream infection (CRBSI), during the ICU stay	after renal replacement therapy session

Secondary Outcome Measures

Name	Time	Method
frequencies of catheter colonization, severe mechanical complications, and adverse events	for two minutes before being withdrawn

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France