Ethanol in the Prevention of Central Venous Catheter Infections

NCT ID: NCT01229592

Last Updated: 2012-07-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-02-29

Brief Summary

In recent years, several new methods for treatment of catheter-related bloodstream infections (CRBSI) such as antibiotic or antiseptic lock-therapy have been developed with variable success [1-10].

Long-term tunnelled central venous catheters provide a reliable access for administration of chemotherapy, parenteral nutrition or haemodialysis. However, they are not free of complications such as bacteremia. The need to preserve these intra-vascular devices as long as is possible in patients in whom conventional treatment was failed makes emerge antibiotic lock-technique.

Ethanol lock-therapy was demonstrate her utility in this cases. But no study has yet been published using the ethanol lock-therapy as a prophylactic therapy in catheter related infections, neither her application in short-term CVCs.

Objectives: To investigate the value of a ethanol-lock solution in the prophylaxis of non-tunnelled short-term CVC related infections in a heart post-surgical intensive care unit (HPSICU).

Methods: An academic, prospective, randomized and controlled clinical trial is proposed. Patients at HPSICU who have a CVC more than 48 h will be randomized in two arms (ethanol-lock or control group with conventional measurements such as anticoagulants). In the follow-up period, we will register all necessary data to evaluate the end-points of study (CBRSI rate, catheter colonization rate, hospital stay, antimicrobial consume and adverse events due to ethanol).

Conditions

Catheter Related Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ethanol

Every three day lock using Ethanol in all the lumen of the Catheter

Group Type: EXPERIMENTAL

Ethanol

Intervention Type: DRUG

Every three day lock using Ethanol(70%)in all the lumen(1ml/per lumen) of the Catheter

Heparine

Every three day lock using Heparine in all the lumen of the Catheter

Group Type: ACTIVE_COMPARATOR

Heparine

Intervention Type: DRUG

Every three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter

Interventions

Ethanol

Every three day lock using Ethanol(70%)in all the lumen(1ml/per lumen) of the Catheter

Intervention Type: DRUG

Heparine

Every three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• older than 18 years old
• Signed informed consent
• central Venous catheter more than 48 hours placed

Exclusion Criteria

• pregnancy
• denial Informed consent Form
• ethanol intolerance
• Liver cirrhosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital General Universitario Gregorio Marañon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Servicio de Microbiología y Enfermedades Infecciosas. Hospital GU Gregorio Marañon

Madrid, Madrid, Spain

Countries

Spain

References

Perez-Granda MJ, Barrio JM, Munoz P, Hortal J, Rincon C, Rabadan PM, Pernia MS, Bouza E. Ethanol lock therapy (E-Lock) in the prevention of catheter-related bloodstream infections (CR-BSI) after major heart surgery (MHS): a randomized clinical trial. PLoS One. 2014 Mar 27;9(3):e91838. doi: 10.1371/journal.pone.0091838. eCollection 2014.

Reference Type: DERIVED

PMID: 24675993 (View on PubMed)

Other Identifiers

2007-007063-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EC07/90653

Identifier Type: -

Identifier Source: org_study_id