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

Sponsor

Stanford University (Other)

Overall Status

Terminated

CT.gov ID

NCT02890875

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Catheter-Related Infections	Other: Ethanol lock Other: Heparin lock	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ethanol lock 70% ethanol	Other: Ethanol lock
Active Comparator: Heparin lock Heparinized saline (100 U/mL)	Other: Heparin lock

Arm

Intervention/Treatment

Active Comparator: Ethanol lock

70% ethanol

Other: Ethanol lock

Active Comparator: Heparin lock

Heparinized saline (100 U/mL)

Other: Heparin lock

Outcome Measures

Primary Outcome Measures

Central line-associated bloodstream infection [12 months]

Secondary Outcome Measures

Hospitalization [12 months]
SIRS/sepsis [12 months]
Catheter-related complication [12 months]
New self-reported symptoms [12 months]

Other Outcome Measures

Microorganism (blood culture, if obtained for clinical reasons) [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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