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 Overview
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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.

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

Official Title
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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.

Conditions
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Acute Renal Failure, Infection

Intervention / Treatment
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* Other: Ethanol


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ethanol<br> | Other: Ethanol<br>* 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.<br>|
| Placebo Comparator: placebo<br> | Other: Ethanol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | after renal replacement therapy session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequencies of catheter colonization, severe mechanical complications, and adverse events |  | for two minutes before being withdrawn | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nosocomial infection, Catheterization, Central Venous Ethanol, lock solution, intensive care units, Renal replacement therapy in ICU