Clinical trial NCT00582010: Study to Evaluate if Inhaled Nitric Oxide Improves Liver Function After Transplantation
Official title: Effects of Inhaled Nitric Oxide on Ischemia-Reperfusion Injury in Human Liver During Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Reperfusion Injury
Liver Injury
Keywords: ischemia-reperfusion
nitric oxide
inflammation
cell-death
Liver-function post transplantation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
name: University of Washington
First posted: 2007-12-28
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 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

Primary outcomes:
measure: Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in AST Levels)
timeFrame: baseline and 96 hours after baseline
measure: Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in ALT Levels)
timeFrame: baseline and 96 hours after baseline
measure: Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Alkaline Phosphatase Levels)
timeFrame: baseline and 96 hours after baseline
measure: Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Prothrombin Times (PT))
timeFrame: baseline and 96 hours after baseline
measure: Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Bilirubin Levels)
timeFrame: baseline and 96 hours after baseline
measure: Change in Rate of Liver Function Recovery Post-transplantation (Decrease in Hepatobiliary Complications)
timeFrame: baseline to 9 months after transplantation
measure: Number of Complications Related to Liver Function Recovery Post-transplantation (Total Complications) at 9 Months Post Surgery
timeFrame: baseline to 9 months post surgery
Secondary outcomes:
measure: Effect of iNO on Hosptial Length of Stay
timeFrame: from surgery through discharge from hospital
measure: Effect of iNO on SICU Stay
timeFrame: baseline to discharge for SICU
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Alabama at Birmingham
name: Rakesh P Patel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Keith A Jones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Devin E Eckhoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: John S Bynon, MD
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: Blair Smith, MD
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: Clark Cross, MD
role: STUDY_CHAIR
affiliation: University of Alabama at Birmingham
name: Luc Frenette, MD
role: STUDY_DIRECTOR
affiliation: University of Washington
name: John D Lang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.