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

Reperfusion Injury Clinical Trial

Official title:

Effects of Inhaled Nitric Oxide on Ischemia-Reperfusion Injury in Human Liver During Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582010
• Other study ID #: F070112003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 20, 2007
• Last updated: November 5, 2014
• Start date: April 2008
• Est. completion date: October 2012

Study information

• Verified date: October 2014
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2012
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Injury
• Reperfusion Injury
• Wounds and Injuries

Intervention

Drug:
• inhaled nitric oxide
inhaled 80ppm for duration of surgery.
• nitrogen gas
inhaled

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Mallinckrodt, University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	baseline and 96 hours after baseline
Primary	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).	baseline and 96 hours after baseline
Primary	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.	baseline and 96 hours after baseline
Primary	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.	baseline and 96 hours after baseline
Primary	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.	baseline and 96 hours after baseline
Primary	Change in Rate of Liver Function Recovery Post-transplantation (Decrease in Hepatobiliary Complications)	Number of complications due to hepatobiliary events.	baseline to 9 months after transplantation
Primary	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	baseline to 9 months post surgery
Secondary	Effect of iNO on Hosptial Length of Stay	number of days subject in hospital after surgery until discharge	from surgery through discharge from hospital
Secondary	Effect of iNO on SICU Stay	Number of minutes after surgery subject remained in SICU	baseline to discharge for SICU