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

University Hospital, Clermont-Ferrand1,460 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

1,460

Conditions

Acute Renal Failure Infection

Interventions

EthanolOTHER

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 Lock is instilling ethanol (or placebo) in each catheter lumen for 2 minutes before being withdrawn.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: after renal replacement therapy session

Secondary Outcomes

frequencies of catheter colonization, severe mechanical complications, and adverse events

Time frame: for two minutes before being withdrawn