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

Not Applicable

Terminated

• Conditions: Catheter-Related Infections
• Interventions: Other: Heparin lock; Other: Ethanol lock

• Registration Number: NCT02890875
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-07
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heparin lock	Heparin lock	Heparinized saline (100 U/mL)
Ethanol lock	Ethanol lock	70% ethanol

Primary Outcome Measures

Name	Time	Method
Central line-associated bloodstream infection	12 months

Secondary Outcome Measures

Name	Time	Method
Catheter-related complication	12 months
New self-reported symptoms	12 months
Hospitalization	12 months
SIRS/sepsis	12 months

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States