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: June 13, 2014
Last verified: June 2014
  Purpose

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.


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.

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • frequencies of catheter colonization, severe mechanical complications, and adverse events [ Time Frame: for two minutes before being withdrawn ] [ Designated as safety issue: Yes ]

Enrollment: 1460
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 Lock is instilling ethanol (or placebo) in each catheter lumen for 2 minutes before being withdrawn.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 Lock is instilling ethanol (or placebo) in each catheter lumen for 2 minutes before being withdrawn.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 major catheter related infections 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 13, 2014
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 July 26, 2014