Efficacy and Safety of Ethanol Lock Therapy for the Prevention of Central Line-associated Bloodstream Infections

April 30, 2019 updated by: Berkeley Limketkai, Stanford University
Patients on long-term parenteral nutrition (PN) are at high risk for central line-associated bloodstream infections (CLABSI). This study evaluates the efficacy and safety of ethanol lock therapy for CLABSI prophylaxis in adult patients on PN.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients (ages 18-80) on PN with silicone-based central venous catheters

Exclusion Criteria:

  • Weight ≤ 50 kg
  • Allergy/hypersensitivity/intolerance to ethanol or heparin
  • Pregnancy or breastfeeding
  • Patient taking metronidazole, disulfiram, or isoniazid
  • History of alcohol abuse
  • History of heparin-induced thrombocytopenia (HIT) or have an active hypocoagulable state

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ethanol lock
70% ethanol
Other: Ethanol lock
ACTIVE_COMPARATOR: Heparin lock
Heparinized saline (100 U/mL)
Other: Heparin lock

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Central line-associated bloodstream infection
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospitalization
Time Frame: 12 months
12 months
SIRS/sepsis
Time Frame: 12 months
12 months
Catheter-related complication
Time Frame: 12 months
12 months
New self-reported symptoms
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Time Frame
Microorganism (blood culture, if obtained for clinical reasons)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (ESTIMATE)

September 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 2, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38195

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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