Randomized, Blinded, Controlled Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Baylor Research Institute
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Evaluate the role of iNO in early ischemia reperfusion injury in marginal liver grafts during human orthotopic liver or liver/kidney transplantation.
Study Overview
Brief Summary
This study is being done to determine if patients receiving (iNO) will have increased liver function and less damage from IR than patients who do not receive (iNO).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 17 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Liver Transplant
Exclusion Criteria
- •Living donor transplants
Arms & Interventions
Inhaled Nitric Oxid
iNO or placebo will be administered at 40 ppm during the procedure starting when the Warm Ischemia Time begins - liver from ice. Stop when patient transported to ICU
Intervention: Inhaled Nitric Oxide (iNO) (Drug)
Placebo Arm (nitrogen)
iNO or placebo will be administered at 40 ppm during the procedure starting when the Warm Ischemia Time begins - liver from ice. Stop when patient transported to ICU
Intervention: Placebo Arm (Nitrogen) (Drug)
Outcomes
Primary Outcomes
Evaluate the role of iNO in early ischemia reperfusion injury in marginal liver grafts during human orthotopic liver or liver/kidney transplantation.
Time Frame: 24 hours to 1 month
Secondary Outcomes
- iNO group will show accelerated restoration of liver allograft function following liver transplantation and this may translate to better clinical outcomes. Marginal grafts may function better in the treated group(1 month to 1 year)