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

Infection Clinical Trial

— ELVIS  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875069
• Other study ID #: CHU-0050
• Status: Completed
• Phase: Phase 3
• First received: April 2, 2009
• Last updated: June 13, 2014
• Start date: April 2009
• Est. completion date: February 2013

Study information

• Verified date: June 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1460
• Est. completion date: February 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Communicable Diseases
• Infection
• Renal Insufficiency

Intervention

Other:
• Ethanol
Dialysis catheter lock performed after renal replacement therapy session. Lock is instilling ethanol (or placebo) in each catheter lumen for 2 minutes before being withdrawn.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	frequencies of catheter colonization, severe mechanical complications, and adverse events		for two minutes before being withdrawn	Yes