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NCT02890875 Clinical Trial

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

Catheter-Related Infections Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02890875
Other study ID # 38195
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date March 2017

Study information
Verified date April 2019
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 3
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Ethanol lock

• Heparin lock

Locations
Country Name City State
United States Stanford University Palo Alto California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Microorganism (blood culture, if obtained for clinical reasons) 12 months
Primary Central line-associated bloodstream infection 12 months
Secondary Hospitalization 12 months
Secondary SIRS/sepsis 12 months
Secondary Catheter-related complication 12 months
Secondary New self-reported symptoms 12 months
See also
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