Ethanol in the Prevention of Central Venous Catheter Infections

Catheter Related Infection Clinical Trial

Official title:

Clinical Study of Ethanol Lock-therapy in the Prevention of Non-tunnelled, Short Term Central Venous Catheter Associated Infections

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01229592
• Other study ID #: EC07/90653
• Secondary ID: 2007-007063-24
• Status: Terminated
• Phase: N/A
• First received: October 18, 2010
• Last updated: July 16, 2012
• Start date: December 2009
• Est. completion date: February 2012

Study information

• Verified date: July 2012
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Catheter Related Infection
• Catheter-Related Infections
• Communicable Diseases
• Infection

Intervention

Drug:
• Ethanol
Every three day lock using Ethanol(70%)in all the lumen(1ml/per lumen) of the Catheter
• Heparine
Every three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter

Locations

Country	Name	City	State
Spain	Servicio de Microbiología y Enfermedades Infecciosas. Hospital GU Gregorio Marañon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	catheter infectionrelated incidence rates	decrease on catheter infection related incidence rates in comparison to the institution incidence figures	2 years	No
Secondary	cathether bacteriaemia related rate	versus Institution rate figures	2 years	No
Secondary	antimicrobial consume	Defined Diary Dosis(DDDs)in both arms	2 years	No