Trial Outcomes & Findings for Study to Evaluate if Inhaled Nitric Oxide Improves Liver Function After Transplantation (NCT NCT00582010)

NCT ID: NCT00582010

Last Updated: 2014-11-06

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 80 participants
• Primary outcome timeframe: baseline and 96 hours after baseline
• Results posted on: 2014-11-06

Participant Flow

Participant milestones

Measure	1. Experimental iNO administration inhaled nitric oxide : inhaled 80ppm for duration of surgery.	2. Placebo Placebo (nitrogen) nitrogen gas : inhaled
Overall Study STARTED	40	40
Overall Study COMPLETED	40	39
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	1. Experimental iNO administration inhaled nitric oxide : inhaled 80ppm for duration of surgery.	2. Placebo Placebo (nitrogen) nitrogen gas : inhaled
Overall Study Death	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Inhaled Nitric Oxide n=40 Participants 80 ppm was administered by inhalation for the duration of surgery	Placebo (Nitrogen Gas) n=40 Participants 80 ppm was administered by inhalation for the duration of surgery	Total n=80 Participants Total of all reporting groups
Age, Continuous	59 years FULL_RANGE 4 • n=5 Participants	61 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 96 hours after baseline

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).

Outcome measures

Measure	Inhaled Nitric Oxide n=40 Participants	Placebo n=39 Participants
Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in AST Levels)	83 percentage change from baseline Standard Deviation 14.6	86.4 percentage change from baseline Standard Deviation 18

PRIMARY outcome

Timeframe: baseline and 96 hours after baseline

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).

Outcome measures

Measure	Inhaled Nitric Oxide n=40 Participants	Placebo n=39 Participants
Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in ALT Levels)	62.3 percentage change from baseline Standard Deviation 26.8	62.4 percentage change from baseline Standard Deviation 34.9

PRIMARY outcome

Timeframe: baseline and 96 hours after baseline

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.

Outcome measures

Measure	Inhaled Nitric Oxide n=40 Participants	Placebo n=39 Participants
Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Alkaline Phosphatase Levels)	239.7 percentage change from baseline Standard Deviation 672.4	55 percentage change from baseline Standard Deviation 96.3

PRIMARY outcome

Timeframe: baseline and 96 hours after baseline

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.

Outcome measures

Measure	Inhaled Nitric Oxide n=40 Participants	Placebo n=39 Participants
Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Prothrombin Times (PT))	48.9 percentage change from baseline Standard Deviation 9.9	25.5 percentage change from baseline Standard Deviation 37.4

PRIMARY outcome

Timeframe: baseline and 96 hours after baseline

A positive percent reflects an decrease; a negative percentage reflects a increase.

Outcome measures

Measure	Inhaled Nitric Oxide n=40 Participants	Placebo n=39 Participants
Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Bilirubin Levels)	6.6 percent change from baseline Standard Deviation 57	0.4 percent change from baseline Standard Deviation 56.7

PRIMARY outcome

Timeframe: baseline to 9 months after transplantation

Number of complications due to hepatobiliary events.

Outcome measures

Measure	Inhaled Nitric Oxide n=40 Participants	Placebo n=39 Participants
Change in Rate of Liver Function Recovery Post-transplantation (Decrease in Hepatobiliary Complications)	2 Complications	5 Complications

PRIMARY outcome

Timeframe: baseline to 9 months post surgery

Number of any complication reported by subjects at 9 months after surgery

Outcome measures

Measure	Inhaled Nitric Oxide n=40 Participants	Placebo n=39 Participants
Number of Complications Related to Liver Function Recovery Post-transplantation (Total Complications) at 9 Months Post Surgery	44 complications	83 complications

SECONDARY outcome

Timeframe: from surgery through discharge from hospital

number of days subject in hospital after surgery until discharge

Outcome measures

Measure	Inhaled Nitric Oxide n=40 Participants	Placebo n=39 Participants
Effect of iNO on Hosptial Length of Stay	9.0 days Interval 7.5 to 15.5	9.0 days Interval 7.0 to 12.5

SECONDARY outcome

Timeframe: baseline to discharge for SICU

Number of minutes after surgery subject remained in SICU

Outcome measures

Measure	Inhaled Nitric Oxide n=40 Participants	Placebo n=39 Participants
Effect of iNO on SICU Stay	2533 minutes Interval 1983.0 to 3075.0	2518 minutes Interval 1703.0 to 3802.0

Adverse Events

1. Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2. Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	1. Experimental n=40 participants at risk iNO administration inhaled nitric oxide : inhaled 80ppm for duration of surgery.	2. Placebo n=39 participants at risk Placebo (nitrogen) nitrogen gas : inhaled
Cardiac disorders Cardiac arrest	0.00% 0/40	2.6% 1/39 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Rakesh Patel

University of Alabama at Birmingham

Phone: 205-934-3411

Email: rakeshp@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60