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)

U

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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