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NCT Number: NCT00875069

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

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.

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Key information

Conditions

Acute Renal Failure Acute Kidney Injury Cross Infection Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Iatrogenic Disease Infection Infections Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ethanol

Other

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 Lock is instilling ethanol (or placebo) in each catheter lumen for 2 minutes before being withdrawn.

Primary outcomes

  1. 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

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

    Time frame: for two minutes before being withdrawn

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study 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.

Acronym: ELVIS

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Apr 3, 2009
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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