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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Hospital General Universitario Gregorio Marañon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Communicable Diseases
Infection
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014