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

Phase 2

Completed

• Conditions: Reperfusion Injury; Liver Injury
• Interventions: Drug: nitrogen gas; Drug: inhaled nitric oxide

• Registration Number: NCT00582010
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-27
• Study First Posted: 2007-12-28
• Study Start: 2008-04
• Primary Completion: 2009-03
• Disposition First Submitted: 2010-10-12
• Disposition First Submitted QC: 2010-11-15
• Disposition First Posted: 2010-11-24
• Study Completion: 2012-10
• Results First Submitted: 2013-09-30
• Status Verified: 2014-10
• Results First Submitted QC: 2014-11-05
• Last Update Submitted: 2014-11-05
• Results First Posted: 2014-11-06
• Last Update Posted: 2014-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2. Placebo	nitrogen gas	Placebo (nitrogen)
1. Experimental	inhaled nitric oxide	iNO administration

Primary Outcome Measures

Name	Time	Method
Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in ALT Levels)	baseline and 96 hours after baseline	The faster the percent decrease ALT reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. . (ALT levels were lower at 96 hours relative to baseline- positive values in data table indicate percent decrease of ALT relative to baseline).
Number of Complications Related to Liver Function Recovery Post-transplantation (Total Complications) at 9 Months Post Surgery	baseline to 9 months post surgery	Number of any complication reported by subjects at 9 months after surgery
Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in AST Levels)	baseline and 96 hours after baseline	The faster the percent decrease of AST reflect the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. The rate was calculated by measuring AST levels at baseline and at 96 hours post baseline. (AST levels were lower at 96 hours relative to baseline- positive values in data table indicate percent decrease of AST relative to baseline).
Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Prothrombin Times (PT))	baseline and 96 hours after baseline	The faster the percent increase of PT reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase.
Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Alkaline Phosphatase Levels)	baseline and 96 hours after baseline	The faster the percent increase of alkaline phosphatase reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an increase; a negative percentage reflects a decrease.
Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Bilirubin Levels)	baseline and 96 hours after baseline	A positive percent reflects an decrease; a negative percentage reflects a increase.
Change in Rate of Liver Function Recovery Post-transplantation (Decrease in Hepatobiliary Complications)	baseline to 9 months after transplantation	Number of complications due to hepatobiliary events.

Secondary Outcome Measures

Name	Time	Method
Effect of iNO on SICU Stay	baseline to discharge for SICU	Number of minutes after surgery subject remained in SICU
Effect of iNO on Hosptial Length of Stay	from surgery through discharge from hospital	number of days subject in hospital after surgery until discharge

Trial Locations

Locations (2)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Washington; 🇺🇸 Seattle, Washington, United States