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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00875069
First received: April 2, 2009
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing dialysis catheter related bloodstream infection in critically ill patients.


Condition Intervention Phase
Acute Renal Failure
Infection
 Other: Ethanol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official 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.

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Dialysis catheter lock performed [ Time Frame: after renal replacement therapy session ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lock is instilling ethanol (or placebo) in each catheter lumen [ Time Frame: for two minutes before being withdrawn ] [ Designated as safety issue: Yes ]

Enrollment: 1300
Study Start Date: April 2009
Study Completion Date: February 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ethanol Other: Ethanol
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 Lock is instilling ethanol (or placebo) in each catheter lumen for 2 minutes before being withdrawn.
Placebo Comparator: placebo Other: Ethanol
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 Lock is instilling ethanol (or placebo) in each catheter lumen for 2 minutes before being withdrawn.

Detailed Description:

The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing dialysis catheter related bloodstream infection in critically ill patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875069

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Bertrand Souweine, Pr University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00875069     History of Changes
Other Study ID Numbers: CHU-0050
Study First Received: April 2, 2009
Last Updated: February 28, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Nosocomial infection
Catheterization
Central Venous Ethanol
 lock solution
intensive care units
Renal replacement therapy in ICU

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Stress, Psychological
Kidney Diseases
Urologic Diseases
Behavioral Symptoms
Ethanol
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013