Study to Evaluate if Inhaled Nitric Oxide Improves Liver Function After Transplantation

The University of Alabama at Birmingham

Status and phase: Completed; Phase 3; Phase 2

Conditions: Liver Injury; Reperfusion Injury

Treatments: Drug: inhaled nitric oxide; Drug: nitrogen gas

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00582010

F070112003

Details and patient eligibility

About

This blinded, placebo-controlled study will administer inhaled nitric oxide to patients undergoing liver transplantation. The purpose of the study is to test if inhaled nitric oxide prevents liver injury associated with the restoration of blood flow. The premise of the current study is provided by previous studies which document a protective effect of inhaled nitric oxide in this clinical setting.

Full description

Specifically, presenting ischemia-reperfusion injury to transplanted livers remains a therapeutic goal in improving liver function and potentially expanding the number of transplantable livers. This study aims to assess the efficacy of inhaled nitric oxide to limit ischemia-reperfusion injury in transplanted livers and by doing so improve liver function post transplantation and decrease patient hospital length of stays.

Enrollment: 80 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients > 19 yr of age scheduled to undergo liver transplantation.

Exclusion criteria

• Patients < 19 yr of age
• Patients undergoing re-transplantation or dual organ transplantation
• Patients with underlying pulmonary complications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

1. Experimental

Experimental group

Description:

iNO administration

Treatment:

Drug: inhaled nitric oxide

2. Placebo

Placebo Comparator group

Description:

Placebo (nitrogen)

Treatment:

Drug: nitrogen gas