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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Alabama at Birmingham.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Ikaria
University of Washington
Information provided by (Responsible Party):
Rakesh Patel, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00582010
First received: December 20, 2007
Last updated: April 17, 2012
Last verified: April 2012
  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 2
Phase 3

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

Resource links provided by NLM:


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 ]

Enrollment: 40
Study Start Date: April 2008
Estimated Study Completion Date: October 2012
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Experimental
iNO administration
Drug: inhaled nitric oxide
inhaled 80ppm for duration of surgery.
Other Name: iNO
Placebo Comparator: 2. Placebo
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Washington
University of Washington
Seattle, Washington, United States, 98195-6540
Sponsors and Collaborators
University of Alabama at Birmingham
Ikaria
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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rakesh Patel, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00582010     History of Changes
Other Study ID Numbers: F070112003
Study First Received: December 20, 2007
Last Updated: April 17, 2012
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

Additional relevant MeSH terms:
Reperfusion Injury
Cardiovascular Diseases
Pathologic Processes
Postoperative Complications
Vascular Diseases
Nitric Oxide
Anti-Asthmatic Agents
Antioxidants
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Endothelium-Dependent Relaxing Factors
Free Radical Scavengers
Gasotransmitters
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 20, 2014