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

NCT00875069 | Completed Phase 3

• 1 other identifier: CHU-0050
• Study Type: interventional
• Target: 1,460
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Renal Failure; Infection

Keywords

Nosocomial infection; Catheterization; Central Venous Ethanol; lock solution; intensive care units; Renal replacement therapy in ICU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• frequencies of catheter colonization, severe mechanical complications, and adverse events

  for two minutes before being withdrawn

Study Arms (2)

ethanol

EXPERIMENTAL

Other: Ethanol

placebo

PLACEBO COMPARATOR

Other: Ethanol

Interventions

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 Lock is instilling ethanol (or placebo) in each catheter lumen for 2 minutes before being withdrawn.

ethanol; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (5)

• Soum E, Timsit JF, Ruckly S, Gruson D, Canet E, Klouche K, Argaud L, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Darmon M, Bohe J, Schwebel C, Bouadma L, Dupuis C, Souweine B, Lautrette A. Predictive factors for severe long-term chronic kidney disease after acute kidney injury requiring renal replacement therapy in critically ill patients: an ancillary study of the ELVIS randomized controlled trial. Crit Care. 2022 Nov 29;26(1):367. doi: 10.1186/s13054-022-04233-4.

  PMID: 36447221 DERIVED

• 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.

  PMID: 35799302 DERIVED

• 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.

  PMID: 35363884 DERIVED

• 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.

  PMID: 34039478 DERIVED

• 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.

  PMID: 25668557 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Infections; Cross Infection

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Bertrand Souweine, Pr

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 3, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: February 1, 2013
• Last Updated: June 16, 2014

Record last verified: 2014-06

Locations

FR (1)