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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890875
Recruitment Status : Terminated (Low recruitment)
First Posted : September 7, 2016
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Berkeley Limketkai, 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.

Condition or disease Intervention/treatment Phase
Catheter-Related Infections Other: Ethanol lock Other: Heparin lock Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : August 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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



Primary Outcome Measures :
  1. Central line-associated bloodstream infection [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Hospitalization [ Time Frame: 12 months ]
  2. SIRS/sepsis [ Time Frame: 12 months ]
  3. Catheter-related complication [ Time Frame: 12 months ]
  4. New self-reported symptoms [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Microorganism (blood culture, if obtained for clinical reasons) [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890875


Locations
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United States, California
Stanford University
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Berkeley Limketkai, MD Stanford University
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Responsible Party: Berkeley Limketkai, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02890875    
Other Study ID Numbers: 38195
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Keywords provided by Berkeley Limketkai, Stanford University:
ethanol lock
parenteral nutrition
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Catheter-Related Infections
Ethanol
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs