Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts

Baylor Research Institute23 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Liver Transplant

Interventions

Inhaled Nitric Oxide (iNO)DRUG

iNO 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

Placebo Arm (Nitrogen)DRUG

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

Eligibility

Sex: ALLMin age: 17 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Liver Transplant Exclusion Criteria: * Living donor transplants

Locations (1)

Baylor Univsersity Medical Center

Dallas, Texas, United States

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

Time frame: 1 month to 1 year

Data from ClinicalTrials.gov

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