Clinical trial NCT00875069: 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
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Renal Failure
Infection
Keywords: Nosocomial infection
Catheterization
Central Venous Ethanol
lock solution
intensive care units
Renal replacement therapy in ICU
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2009-04-03
Enrollment: 1460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: after renal replacement therapy session
Secondary outcomes:
measure: frequencies of catheter colonization, severe mechanical complications, and adverse events
timeFrame: for two minutes before being withdrawn
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Bertrand Souweine, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.
citation: Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis. Cochrane Database Syst Rev. 2022 Apr 1;4(4):CD013554. doi: 10.1002/14651858.CD013554.pub2.
citation: Boyer A, Timsit JF, Klouche K, Canet E, Phan TN, Bohe J, Rubin S, Orieux A, Lautrette A, Gruson D, Souweine B. Aminoglycosides in Critically Ill Septic Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy: A Multicenter, Observational Study. Clin Ther. 2021 Jun;43(6):1116-1124. doi: 10.1016/j.clinthera.2021.04.011. Epub 2021 May 24.
citation: Souweine B, Lautrette A, Gruson D, Canet E, Klouche K, Argaud L, Bohe J, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Cointault O, Lepape A, Guelon D, Darmon M, Vesin A, Caillot N, Schwebel C, Boyer A, Azoulay E, Bouadma L, Timsit JF. Ethanol lock and risk of hemodialysis catheter infection in critically ill patients. A randomized controlled trial. Am J Respir Crit Care Med. 2015 May 1;191(9):1024-32. doi: 10.1164/rccm.201408-1431OC.