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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00875069

Acronym

ELVIS

Enrollment

1460

Registered

2009-04-03

Start date

2009-04-01

Completion date

2013-02-01

Last updated

2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure, Infection

Keywords

Nosocomial infection, Catheterization, Central Venous Ethanol, lock solution, intensive care units, Renal replacement therapy in ICU

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

Interventions

OTHEREthanol

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 Lock is instilling ethanol (or placebo) in each catheter lumen for 2 minutes before being withdrawn.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

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frequencies of catheter colonization, severe mechanical complications, and adverse events	for two minutes before being withdrawn

Countries

France

Contacts

PRINCIPAL_INVESTIGATORBertrand Souweine, Pr

University Hospital, Clermont-Ferrand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026