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

This study is currently recruiting participants.

Verified by University of Alabama at Birmingham, August 2008

First Received: December 20, 2007 Last Updated: August 25, 2008 History of Changes

Sponsors and Collaborators:	University of Alabama at Birmingham Ikaria (formerly INO Therapeutic) University of Washington
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00582010

Purpose

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.

Condition	Intervention	Phase
Reperfusion Injury Liver Injury	Drug: inhaled nitric oxide Drug: nitrogen gas	Phase II Phase III

Drug Information available for: Nitric oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of Inhaled Nitric Oxide on Ischemia-Reperfusion Injury in Human Liver During Transplantation

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

Improved rate of liver function recovery post-transplantation [ Time Frame: 0-4 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Decreases length of stay in hospital [ Time Frame: days-weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. Experimental: Experimental iNO administration	Drug: inhaled nitric oxide inhaled 80ppm for duration of surgery.
2. Placebo: Placebo Comparator Placebo (nitrogen)	Drug: nitrogen gas inhaled

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.

Eligibility

Ages Eligible for Study:	19 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582010

Contacts

Contact: Rakesh P Patel, PhD

205-975-9225

rakeshp@uab.edu

Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35294
Contact: Rakesh P Patel, PhD 205-975-9225 rakeshp@uab.edu
United States, Washington
University of Washington	Not yet recruiting
Seattle, Washington, United States, 98195-6540
Contact: John D Lang, MD 206-764-2854
Principal Investigator: John D Lang, MD

Sponsors and Collaborators

University of Alabama at Birmingham

Ikaria (formerly INO Therapeutic)

University of Washington

Investigators

Principal Investigator:	Rakesh P Patel, PhD	University of Alabama at Birmingham
Principal Investigator:	Keith A Jones, MD	University of Alabama at Birmingham
Principal Investigator:	Devin E Eckhoff, MD	University of Alabama at Birmingham
Study Director:	John S Bynon, MD	University of Alabama at Birmingham
Study Director:	Blair Smith, MD	University of Alabama at Birmingham
Study Chair:	Clark Cross, MD	University of Alabama at Birmingham
Study Director:	Luc Frenette, MD	University of Alabama at Birmingham
Principal Investigator:	John D Lang, MD	University of Washington

More Information

Publications:

Lang JD Jr, Teng X, Chumley P, Crawford JH, Isbell TS, Chacko BK, Liu Y, Jhala N, Crowe DR, Smith AB, Cross RC, Frenette L, Kelley EE, Wilhite DW, Hall CR, Page GP, Fallon MB, Bynon JS, Eckhoff DE, Patel RP. Inhaled NO accelerates restoration of liver function in adults following orthotopic liver transplantation. J Clin Invest. 2007 Sep;117(9):2583-91.

Responsible Party:	University of Alabama at Birmingham and University of Washington ( Rakesh P Patel - Associate Professor (UAB), John D Lang - Associate Professor (UW) )
Study ID Numbers:	F070112003
Study First Received:	December 20, 2007
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00582010 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:

ischemia-reperfusion
nitric oxide
inflammation
cell-death
Liver-function post transplantation

Study placed in the following topic categories:

Death
Neurotransmitter Agents
Vasodilator Agents
Antioxidants
Vascular Diseases
Anti-Asthmatic Agents
Cardiovascular Agents

Ischemia
Inflammation
Nitric Oxide
Postoperative Complications
Peripheral Nervous System Agents
Bronchodilator Agents
Reperfusion Injury

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vascular Diseases
Anti-Asthmatic Agents
Cardiovascular Agents
Protective Agents
Pharmacologic Actions

Nitric Oxide
Pathologic Processes
Postoperative Complications
Autonomic Agents
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Cardiovascular Diseases
Peripheral Nervous System Agents
Bronchodilator Agents
Reperfusion Injury

ClinicalTrials.gov processed this record on May 07, 2009