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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-02-28

Brief Summary

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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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Detailed Description

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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

Conditions

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Acute Renal Failure Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ethanol

Group Type EXPERIMENTAL

Ethanol

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 Lock is instilling ethanol (or placebo) in each catheter lumen for 2 minutes before being withdrawn.

placebo

Group Type PLACEBO_COMPARATOR

Ethanol

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 Lock is instilling ethanol (or placebo) in each catheter lumen for 2 minutes before being withdrawn.

Interventions

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 Lock is instilling ethanol (or placebo) in each catheter lumen for 2 minutes before being withdrawn.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No