Catheter-Related Infections Clinical Trial
Official title:
Efficacy and Safety of Ethanol Lock Therapy for the Prevention of Central Line-associated Bloodstream Infections
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 |
Verified date | April 2019 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
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 |
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