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

Primary Purpose

Catheter-Related Infections

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ethanol lock
Heparin lock
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Catheter-Related Infections focused on measuring ethanol lock, parenteral nutrition

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ethanol lock

Heparin lock

Arm Description

70% ethanol

Heparinized saline (100 U/mL)

Outcomes

Primary Outcome Measures

Central line-associated bloodstream infection

Secondary Outcome Measures

Hospitalization
SIRS/sepsis
Catheter-related complication
New self-reported symptoms

Full Information

First Posted
August 29, 2016
Last Updated
April 30, 2019
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02890875
Brief Title
Efficacy and Safety of Ethanol Lock Therapy for the Prevention of Central Line-associated Bloodstream Infections
Official Title
Efficacy and Safety of Ethanol Lock Therapy for the Prevention of Central Line-associated Bloodstream Infections
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter-Related Infections
Keywords
ethanol lock, parenteral nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ethanol lock
Arm Type
Active Comparator
Arm Description
70% ethanol
Arm Title
Heparin lock
Arm Type
Active Comparator
Arm Description
Heparinized saline (100 U/mL)
Intervention Type
Other
Intervention Name(s)
Ethanol lock
Intervention Type
Other
Intervention Name(s)
Heparin lock
Primary Outcome Measure Information:
Title
Central line-associated bloodstream infection
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Hospitalization
Time Frame
12 months
Title
SIRS/sepsis
Time Frame
12 months
Title
Catheter-related complication
Time Frame
12 months
Title
New self-reported symptoms
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Microorganism (blood culture, if obtained for clinical reasons)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berkeley Limketkai, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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