NCT02890875

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

August 29, 2016

Last Update Submit

April 30, 2019

Conditions

Catheter-Related Infections

Keywords

ethanol lockparenteral nutrition

Outcome Measures

Primary Outcomes (1)

  • Central line-associated bloodstream infection

    12 months

Secondary Outcomes (4)

  • Hospitalization

    12 months

  • SIRS/sepsis

    12 months

  • Catheter-related complication

    12 months

  • New self-reported symptoms

    12 months

Other Outcomes (1)

  • Microorganism (blood culture, if obtained for clinical reasons)

    12 months

Study Arms (2)

Ethanol lock

ACTIVE COMPARATOR

70% ethanol

Other: Ethanol lock

Heparin lock

ACTIVE COMPARATOR

Heparinized saline (100 U/mL)

Other: Heparin lock

Interventions

Ethanol lockOTHER
Ethanol lock
Heparin lockOTHER
Heparin lock

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (ages 18-80) on PN with silicone-based central venous catheters

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Catheter-Related InfectionsHyperphagia

Interventions

Vascular Access Devices

Condition Hierarchy (Ancestors)

InfectionsSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CathetersEquipment and Supplies

Study Officials

  • Berkeley Limketkai, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 7, 2016

Study Start

August 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

May 2, 2019

Record last verified: 2019-04

Locations

US(1)