Ethanol in the Prevention of Central Venous Catheter Infections

This study has been terminated.
(The non significative reduction of CRBSI adverse events,the need for a high frecuency of catheter manipulations)
Sponsor:
Information provided by (Responsible Party):
Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier:
NCT01229592
First received: October 18, 2010
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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).


Condition Intervention
Catheter Related Infection
Drug: Ethanol
Drug: Heparine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Clinical Study of Ethanol Lock-therapy in the Prevention of Non-tunnelled, Short Term Central Venous Catheter Associated Infections

Further study details as provided by Hospital General Universitario Gregorio Marañon:

Primary Outcome Measures:
  • catheter infectionrelated incidence rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    decrease on catheter infection related incidence rates in comparison to the institution incidence figures


Secondary Outcome Measures:
  • cathether bacteriaemia related rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    versus Institution rate figures

  • antimicrobial consume [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Defined Diary Dosis(DDDs)in both arms


Enrollment: 200
Study Start Date: December 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ethanol
Every three day lock using Ethanol in all the lumen of the Catheter
Drug: Ethanol
Every three day lock using Ethanol(70%)in all the lumen(1ml/per lumen) of the Catheter
Active Comparator: Heparine
Every three day lock using Heparine in all the lumen of the Catheter
Drug: Heparine
Every three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229592

Locations
Spain
Servicio de Microbiología y Enfermedades Infecciosas. Hospital GU Gregorio Marañon
Madrid, Spain, 28007
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
  More Information

No publications provided

Responsible Party: Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT01229592     History of Changes
Other Study ID Numbers: EC07/90653, 2007-007063-24
Study First Received: October 18, 2010
Last Updated: July 16, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Hospital General Universitario Gregorio Marañon:
infection
catheter
bacteriaemia
ethanol

Additional relevant MeSH terms:
Catheter-Related Infections
Infection
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014