Trial Outcomes & Findings for Effect of Nitric Oxide (NO) on Ischemic/Reperfusion Injury During Extended Donor Criteria (EDC) Liver Transplantation (NCT NCT00948194)

NCT ID: NCT00948194

Last Updated: 2021-05-28

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2021-05-28

Participant Flow

Participant milestones

Measure	No Nitric Oxide This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics	Nitric Oxide Will receive Nitric oxide and other standard inhaled anesthetics Nitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery
Overall Study STARTED	6	7
Overall Study COMPLETED	5	7
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	No Nitric Oxide This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics	Nitric Oxide Will receive Nitric oxide and other standard inhaled anesthetics Nitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery
Overall Study Blood drawn using incorrect test tube; sample invalid	1	0

Baseline Characteristics

Effect of Nitric Oxide (NO) on Ischemic/Reperfusion Injury During Extended Donor Criteria (EDC) Liver Transplantation

Baseline characteristics by cohort

Measure	No Nitric Oxide n=5 Participants This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics	Nitric Oxide n=7 Participants Will receive Nitric oxide and other standard inhaled anesthetics Nitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Diagnosis Cirrhosis	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Diagnosis Hepatitis C	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Diagnosis HCC	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Diagnosis Hepatoma	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants
Diagnosis Primary Sclerosing Cholangitis (PSC)	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Diagnosis Fatty Liver (NASH)	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Diagnosis Metabolic Disease (METDIS) - Alpha-1-Antitrypsin Deficiency (A-1-A)	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Diagnosis Bone mets	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Model for End-Stage Liver Disease Score	26.2 units on a scale STANDARD_DEVIATION 5.42 • n=5 Participants	27.14 units on a scale STANDARD_DEVIATION 3.64 • n=7 Participants	26.75 units on a scale STANDARD_DEVIATION 4.5 • n=5 Participants
BMI	26.59 kg/m^2 STANDARD_DEVIATION 5.01 • n=5 Participants	27.1 kg/m^2 STANDARD_DEVIATION 5.83 • n=7 Participants	26.89 kg/m^2 STANDARD_DEVIATION 5.51 • n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: The outcome measure data are unavailable. This study was terminated when the P.I. left the university. Research Administration and the study team have made numerous unsuccessful attempts to obtain the outcome measure data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Population: The outcome measure data are unavailable. This study was terminated when the P.I. left the university. Research Administration and the study team have made numerous unsuccessful attempts to obtain the outcome measure data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Population: The outcome measure data are unavailable. This study was terminated when the P.I. left the university. Research Administration and the study team have made numerous unsuccessful attempts to obtain the outcome measure data.

Outcome measures

Outcome data not reported

Adverse Events

No Nitric Oxide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nitric Oxide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nick Naughton

University of Colorado Denver

Phone: 303-724-0833

Email: nick.naughton@cuanschutz.edu

Results disclosure agreements

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