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Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ikaria Holdings Inc.
Information provided by:
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01172691
First received: July 28, 2010
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

This study is being done to determine if patients receiving (iNO) will have increased liver function and less damage from IR than patients who do not receive (iNO).


Condition Intervention Phase
Liver Transplant
 Procedure: Inhaled Nitric Oxide (iNO)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Blinded, Controlled Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • Evaluate the role of iNO in early ischemia reperfusion injury in marginal liver grafts during human orthotopic liver or liver/kidney transplantation. [ Time Frame: 24 hours to 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • iNO group will show accelerated restoration of liver allograft function following liver transplantation and this may translate to better clinical outcomes. Marginal grafts may function better in the treated group [ Time Frame: 1 month to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 2
Study Start Date: July 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo and Study Procedure: Inhaled Nitric Oxide (iNO)
iNO or placebo will be administered at 40 ppm during the procedure starting when the Warm Ischemia Time begins - liver from ice. Stop when patient transported to ICU

  Eligibility

Ages Eligible for Study:   17 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Liver Transplant

Exclusion Criteria:

  • Living donor transplants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172691

Locations
United States, Texas
Baylor Univsersity Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
Ikaria Holdings Inc.
Investigators
Principal Investigator: Michael A Ramsay, MD Baylor Health Care System
  More Information

No publications provided

Responsible Party: Michael Ramsay, MD, FRCA President BRI, Chairman of Department of Anesthesiology and Pain Management - BUMC
ClinicalTrials.gov Identifier: NCT01172691     History of Changes
Other Study ID Numbers: 010-085
Study First Received: July 28, 2010
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor Research Institute:
Liver transplant

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

ClinicalTrials.gov processed this record on May 22, 2013