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Sponsors and Collaborators: |
University of Alabama at Birmingham Ikaria (formerly INO Therapeutic) University of Washington |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00582010 |
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 |
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Reperfusion Injury Liver Injury |
Drug: inhaled nitric oxide Drug: nitrogen gas |
Phase II Phase III |
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 |
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 |
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1. Experimental: Experimental
iNO administration
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Drug: inhaled nitric oxide
inhaled 80ppm for duration of surgery.
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2. Placebo: Placebo Comparator
Placebo (nitrogen)
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Drug: nitrogen gas
inhaled
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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.
Ages Eligible for Study: | 19 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rakesh P Patel, PhD | 205-975-9225 | rakeshp@uab.edu |
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 |
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 |
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 |
Health Authority: | United States: Food and Drug Administration |
ischemia-reperfusion nitric oxide inflammation cell-death Liver-function post transplantation |
Nitric Oxide Death Postoperative Complications Vascular Diseases |
Ischemia Inflammation Reperfusion Injury |
Respiratory System Agents Vasodilator Agents Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents Cardiovascular Agents Protective Agents |
Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors Cardiovascular Diseases Peripheral Nervous System Agents Bronchodilator Agents |