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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Catheter-Related Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ethanol lock

70% ethanol

Group Type ACTIVE_COMPARATOR

Ethanol lock

Intervention Type OTHER

Heparin lock

Heparinized saline (100 U/mL)

Group Type ACTIVE_COMPARATOR

Heparin lock

Intervention Type OTHER

Interventions

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Ethanol lock

Intervention Type OTHER

Heparin lock

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No