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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
inhaled 80ppm for duration of surgery.
inhaled
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Washington
Seattle, Washington, United States
Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in AST Levels)
The faster the percent decrease of AST reflect the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. The rate was calculated by measuring AST levels at baseline and at 96 hours post baseline. (AST levels were lower at 96 hours relative to baseline- positive values in data table indicate percent decrease of AST relative to baseline).
Time frame: baseline and 96 hours after baseline
Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in ALT Levels)
The faster the percent decrease ALT reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. . (ALT levels were lower at 96 hours relative to baseline- positive values in data table indicate percent decrease of ALT relative to baseline).
Time frame: baseline and 96 hours after baseline
Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Alkaline Phosphatase Levels)
The faster the percent increase of alkaline phosphatase reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an increase; a negative percentage reflects a decrease.
Time frame: baseline and 96 hours after baseline
Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Prothrombin Times (PT))
The faster the percent increase of PT reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase.
Time frame: baseline and 96 hours after baseline
Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Bilirubin Levels)
A positive percent reflects an decrease; a negative percentage reflects a increase.
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Time frame: baseline and 96 hours after baseline
Change in Rate of Liver Function Recovery Post-transplantation (Decrease in Hepatobiliary Complications)
Number of complications due to hepatobiliary events.
Time frame: baseline to 9 months after transplantation
Number of Complications Related to Liver Function Recovery Post-transplantation (Total Complications) at 9 Months Post Surgery
Number of any complication reported by subjects at 9 months after surgery
Time frame: baseline to 9 months post surgery
Effect of iNO on Hosptial Length of Stay
number of days subject in hospital after surgery until discharge
Time frame: from surgery through discharge from hospital
Effect of iNO on SICU Stay
Number of minutes after surgery subject remained in SICU
Time frame: baseline to discharge for SICU