NCT00875069CompletedPhase 3
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.
University Hospital, Clermont-Ferrand2 sites in 1 country1,460 target enrollmentStarted: April 1, 2009Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 1,460
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ethanol
Experimental
Intervention: Ethanol (Other)
placebo
Placebo Comparator
Intervention: Ethanol (Other)
Outcomes
Primary Outcomes
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
- frequencies of catheter colonization, severe mechanical complications, and adverse events(for two minutes before being withdrawn)
Investigators
Study Sites (2)
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