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 (ELVIS)

University Hospital, Clermont-Ferrand

Status and phase: Completed; Phase 3

Conditions: Infection; Acute Renal Failure

Treatments: Other: Ethanol

Study type: Interventional

Funder types: Other

Identifiers

NCT00875069

CHU-0050

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,460 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,460 participants in 2 patient groups, including a placebo group

ethanol

Experimental group

Treatment:

Other: Ethanol

placebo

Placebo Comparator group

Treatment:

Other: Ethanol