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

NCT ID: NCT00582010

Last Updated: 2014-11-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Reperfusion Injury Liver Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1. Experimental

iNO administration

Group Type EXPERIMENTAL

inhaled nitric oxide

Intervention Type DRUG

inhaled 80ppm for duration of surgery.

2. Placebo

Placebo (nitrogen)

Group Type PLACEBO_COMPARATOR

nitrogen gas

Intervention Type DRUG

inhaled

Interventions

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inhaled nitric oxide

inhaled 80ppm for duration of surgery.

Intervention Type DRUG

nitrogen gas

inhaled

Intervention Type DRUG

Other Intervention Names

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iNO

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mallinckrodt

INDUSTRY

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Rakesh Patel

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rakesh P Patel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Keith A Jones, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Devin E Eckhoff, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

John S Bynon, MD

Role: STUDY_DIRECTOR

University of Alabama at Birmingham

Blair Smith, MD

Role: STUDY_DIRECTOR

University of Alabama at Birmingham

Clark Cross, MD

Role: STUDY_CHAIR

University of Alabama at Birmingham

Luc Frenette, MD

Role: STUDY_DIRECTOR

University of Alabama at Birmingham

John D Lang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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. doi: 10.1172/JCI31892.

Reference Type BACKGROUND
PMID: 17717604 (View on PubMed)

Lang JD Jr, Smith AB, Brandon A, Bradley KM, Liu Y, Li W, Crowe DR, Jhala NC, Cross RC, Frenette L, Martay K, Vater YL, Vitin AA, Dembo GA, Dubay DA, Bynon JS, Szychowski JM, Reyes JD, Halldorson JB, Rayhill SC, Dick AA, Bakthavatsalam R, Brandenberger J, Broeckel-Elrod JA, Sissons-Ross L, Jordan T, Chen LY, Siriussawakul A, Eckhoff DE, Patel RP. A randomized clinical trial testing the anti-inflammatory effects of preemptive inhaled nitric oxide in human liver transplantation. PLoS One. 2014 Feb 12;9(2):e86053. doi: 10.1371/journal.pone.0086053. eCollection 2014.

Reference Type DERIVED
PMID: 24533048 (View on PubMed)

Other Identifiers

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F070112003

Identifier Type: -

Identifier Source: org_study_id

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