Skip to main content
OpenTrials
Completed

NCT Number: NCT00582010

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Reperfusion Injury Cardiovascular Diseases Inflammation Liver Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Vascular Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhaled Nitric Oxide

Drug

inhaled 80ppm for duration of surgery.

Other names: iNO

nitrogen gas

Drug

inhaled

Primary outcomes

  1. Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in AST Levels)

    Time frame: 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).

  2. Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in ALT Levels)

    Time frame: 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).

  3. Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Alkaline Phosphatase Levels)

    Time frame: 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.

  4. Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Prothrombin Times (PT))

    Time frame: 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.

  5. Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Bilirubin Levels)

    Time frame: baseline and 96 hours after baseline

    A positive percent reflects an decrease; a negative percentage reflects a increase.

  6. Change in Rate of Liver Function Recovery Post-transplantation (Decrease in Hepatobiliary Complications)

    Time frame: baseline to 9 months after transplantation

    Number of complications due to hepatobiliary events.

  7. Number of Complications Related to Liver Function Recovery Post-transplantation (Total Complications) at 9 Months Post Surgery

    Time frame: baseline to 9 months post surgery

    Number of any complication reported by subjects at 9 months after surgery

Secondary outcomes

  1. Effect of iNO on Hosptial Length of Stay

    Time frame: from surgery through discharge from hospital

    number of days subject in hospital after surgery until discharge

  2. Effect of iNO on SICU Stay

    Time frame: baseline to discharge for SICU

    Number of minutes after surgery subject remained in SICU

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Mallinckrodt
  • University of Washington

Registry information

Official study title

Effects of Inhaled Nitric Oxide on Ischemia-Reperfusion Injury in Human Liver During Transplantation

Important dates

Study start
2008
Primary completion
2009
Study completion
2012
First posted
Dec 28, 2007
Registry last updated
Nov 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.