Alcohol Locks for the Prevention of Tunneled Catheter-related Infections

This study has been completed.
Sponsor:
Collaborator:
Stichting Nuts Ohra
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00122642
First received: July 19, 2005
Last updated: September 24, 2009
Last verified: September 2009
  Purpose

In modern-day medicine, the use of central venous catheters has become unavoidable. However, their use does not come without risk. It puts patients in danger of infectious complications (catheter-related infections [CRI]), the most important of which is catheter-related bloodstream infection (CRBSI). CRBSI is associated with a significant increase in hospital stay and, therefore, cost of patient management, morbidity, and probably also mortality. There still is an urgent need for effective, cheap and easy to implement measures to prevent CRI that are without risk of developing antibiotic resistance.

During use, bacteria can colonize the inner surface of the catheter. This endoluminal route of infection can be prevented to some extent when an antibiotic solution is instilled in the catheter for a long enough time and on a regular basis. However, to avoid resistance from occurring, the use of antibiotics for infection prevention should remain exceptional.

The use of a non-toxic antiseptic might be a better alternative. Recently, the use of an alcohol lock solution was suggested as a promising way to prevent CRBSI and the compatibility of polyurethane and silicone catheters submerged in an alcohol solution was publicized with no biomechanical or structural changes detected after 9 weeks of immersion. The major advantage of an alcohol lock solution would be the broad antimicrobial spectrum without the risk of compromising future antibiotic treatment as, in contrast to the use of an antibiotic lock, the development of antibiotic resistance is not of concern. Furthermore it would be cheap and universally available.

In this randomised study, the efficacy of a 70% alcohol lock solution for the prevention of CRBSI will be compared with placebo when applied for 15 minutes per day.


Condition Intervention Phase
Bacteremia
Procedure: Alcohol-lock
Drug: placebo-lock
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Short Daily Alcohol Locks for the Prevention of Tunneled Catheter Infection in Patients With Haematological Disease. Randomised Placebo Controlled Trial

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • Endoluminal catheter related bacteremia [ Time Frame: at time of catheter removal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All catheter-related bacteremias with differential time to positivity (DTTP) > 2 hours [ Time Frame: at time of catheter removal ] [ Designated as safety issue: No ]
  • Catheter survival time [ Time Frame: at time of catheter removal ] [ Designated as safety issue: No ]
  • Vancomycin and linezolid use [ Time Frame: at time of catheter removal ] [ Designated as safety issue: No ]
  • Incidence of positive catheter tip cultures [ Time Frame: at time of catheter removal ] [ Designated as safety issue: No ]
  • Incidence of bacteremia/fungemia (catheter-related or not) [ Time Frame: at time of catheter removal ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: August 2005
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
The intervention is the instillation of ethanol 70% solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes for patients not in the hospital.
Procedure: Alcohol-lock
The intervention is the instillation of ethanol 70% solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital.
Placebo Comparator: 2
The intervention is the instillation of placebo solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital.
Drug: placebo-lock
The intervention is the instillation of placebo solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital.

Detailed Description:

In modern-day medicine, the use of intravascular catheters has become unavoidable. In the United States, hospitals and clinics purchase more than 150 million intravascular devices each year of which more than 5 million are central venous catheters. However, their use does not come without risk. It puts patients in danger of mechanical, thrombotic and infectious complications (catheter-related infections [CRI]), the most important of which is catheter-related bloodstream infection (CRBSI). CRBSI is associated with a significant increase in hospital stay and, therefore, cost of patient management, morbidity and probably also mortality. The increase in expenses was estimated to be 15,965 US dollars per patient with a CRBSI in 1994 and even 56,167 US dollars in another more recent study.

It is clear that the prevention of CRI is of utmost importance and will help to decrease patient suffering as well as cost of patient management. Extensive and detailed evidence-based recommendations for the prevention of CRI were recently published. However, many topics remain unresolved and there still is an urgent need for effective, cheap and easy to implement preventive measures that are without risk of developing antibiotic resistance.

Catheters can become colonized with microorganisms through exoluminal (catheter insertion site) or endoluminal (hub and infusates) routes. It has been shown that, the longer a catheter remains in place, the more important the endoluminal route becomes. The endoluminal route of infection can be prevented to some extent when an antibiotic solution is instilled in the catheter for a long enough time and on a regular basis. However, to avoid resistance from occurring, the use of antibiotics in such a lock for infection prevention should remain exceptional. Although there is evidence to support the concept, methodologically appropriate clinical data on the use of antiseptic solutions for this purpose are still awaited.

Recently, the use of an alcohol lock solution was suggested as a promising way to prevent CRBSI and the compatibility of polyurethane and silicone catheters submerged in an alcohol solution was publicized with no biomechanical or structural changes detected after 9 weeks of immersion. The major advantage of an alcohol lock solution would be the broad antimicrobial spectrum without the risk of compromising future antibiotic treatment as, in contrast to the use of an antibiotic lock, the development of antibiotic resistance is not of concern. Furthermore it would be cheap and universally available.

In this randomised study the efficacy of a 70% alcohol lock solution for the prevention of CRBSI will be compared with placebo when applied for 15 minutes per day.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient at least 18 years old
  • Admitted to the haematology department
  • Had a tunnelled central venous catheter inserted in the preceding 72 hours

Exclusion Criteria:

  • Known allergy to alcohol or active use of metronidazole (or related 2-nitroimidazole compounds) or disulfiram (Antabuse)
  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: NCT00122642

Locations
Netherlands
Erasmus Medical Center
Rotterdam, Netherlands, 3000 CA
Sponsors and Collaborators
Erasmus Medical Center
Stichting Nuts Ohra
Investigators
Principal Investigator: Bart JA Rijnders, MD, PhD Erasmus Medical Center
  More Information

Publications:
Maki DG, Crnich CJ, Safdar N. Successful use of a 25% Alcohol Lock Solution for Prevention of Recurrent CVC-Related Bloodstream Infection in a patient on Home TNA. 42nd ICAAC Abstracts, American Society for Microbiology, September 27 - 30, 2002, San Diego, CA, page 320 . 2002.
A.Aiyangar, W.C.Crone, C.J.Crnich DGM. Effect of Ethanol on the Mechanical Properties of Polyurethane Catheters. Proceedings of the 2002 SEM Annual Conference and Exposition on Experimental and Applied Mechanics . 2002.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: BJ, Rijnders
ClinicalTrials.gov Identifier: NCT00122642     History of Changes
Other Study ID Numbers: AL-01, SNO-T-07-57
Study First Received: July 19, 2005
Last Updated: September 24, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
catheterization
Catheters, Indwelling

Additional relevant MeSH terms:
Bacteremia
Catheter-Related Infections
Bacterial Infections
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome
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 October 20, 2014