Trial Outcomes & Findings for Postoperative Heme Oxygenase Induction and Carbon Monoxide Production as a Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy (NCT NCT04195438)

NCT ID: NCT04195438

Last Updated: 2024-06-21

Results Overview

Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2024-06-21

Participant Flow

Participant milestones

Measure	Intervention Arm CO and ABG Testing Arm CO Testing Pre/Post Hepatic Resection: Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH ABG Testing Pre/Post Hepatic Resection: Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH CT Evaluations: Analyze the relationship between CO production and the extent of hepatic resection assessed by computed scans liver volumetric study at one and three months after PH, size and weight of the resected specimen and operative report
Overall Study STARTED	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Intervention Arm CO and ABG Testing Arm CO Testing Pre/Post Hepatic Resection: Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH ABG Testing Pre/Post Hepatic Resection: Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH CT Evaluations: Analyze the relationship between CO production and the extent of hepatic resection assessed by computed scans liver volumetric study at one and three months after PH, size and weight of the resected specimen and operative report

Overall Study Withdrawal by Subject

1

Baseline Characteristics

Postoperative Heme Oxygenase Induction and Carbon Monoxide Production as a Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy

Baseline characteristics by cohort

Measure	Intervention Arm n=24 Participants CO and ABG Testing Arm CO Testing Pre/Post Hepatic Resection: Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH ABG Testing Pre/Post Hepatic Resection: Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH CT Evaluations: Analyze the relationship between CO production and the extent of hepatic resection assessed by computed scans liver volumetric study at one and three months after PH, size and weight of the resected specimen and operative report
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection

Outcome measures

Measure

Intervention Arm n=24 Participants CO and ABG Testing Arm CO Testing Pre/Post Hepatic Resection: Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH ABG Testing Pre/Post Hepatic Resection: Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH CT Evaluations: Analyze the relationship between CO production and the extent of hepatic resection assessed by computed scans liver volumetric study at one and three months after PH, size and weight of the resected specimen and operative report

CO Output (Ppm)

2.03 ppm Standard Deviation 0.82

PRIMARY outcome

Timeframe: Baseline

Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection

Outcome measures

Measure

Intervention Arm n=24 Participants CO and ABG Testing Arm CO Testing Pre/Post Hepatic Resection: Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH ABG Testing Pre/Post Hepatic Resection: Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH CT Evaluations: Analyze the relationship between CO production and the extent of hepatic resection assessed by computed scans liver volumetric study at one and three months after PH, size and weight of the resected specimen and operative report

ABG (COHb)

1.58 percentage of Carboxyhemoglobin Interval 0.5 to 6.2

PRIMARY outcome

Timeframe: 4 hours post resection

Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection

Outcome measures

Measure

Intervention Arm n=24 Participants CO and ABG Testing Arm CO Testing Pre/Post Hepatic Resection: Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH ABG Testing Pre/Post Hepatic Resection: Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH CT Evaluations: Analyze the relationship between CO production and the extent of hepatic resection assessed by computed scans liver volumetric study at one and three months after PH, size and weight of the resected specimen and operative report

CO Output (Ppm)

3.11 ppm Standard Deviation 1.42

PRIMARY outcome

Timeframe: 4 hours post resection

Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection

Outcome measures

Measure

Intervention Arm n=24 Participants CO and ABG Testing Arm CO Testing Pre/Post Hepatic Resection: Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH ABG Testing Pre/Post Hepatic Resection: Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH CT Evaluations: Analyze the relationship between CO production and the extent of hepatic resection assessed by computed scans liver volumetric study at one and three months after PH, size and weight of the resected specimen and operative report

ABG (COHb)

1.41 percentage of Carboxyhemoglobin Interval 0.4 to 2.8

PRIMARY outcome

Timeframe: 24 hours post resection

Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection

Outcome measures

Measure

Intervention Arm n=24 Participants CO and ABG Testing Arm CO Testing Pre/Post Hepatic Resection: Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH ABG Testing Pre/Post Hepatic Resection: Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH CT Evaluations: Analyze the relationship between CO production and the extent of hepatic resection assessed by computed scans liver volumetric study at one and three months after PH, size and weight of the resected specimen and operative report

CO Output (Ppm)

3.00 ppm Standard Deviation 1.41

PRIMARY outcome

Timeframe: 24 hours post resection

Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection

Outcome measures

Measure

Intervention Arm n=24 Participants CO and ABG Testing Arm CO Testing Pre/Post Hepatic Resection: Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH ABG Testing Pre/Post Hepatic Resection: Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH CT Evaluations: Analyze the relationship between CO production and the extent of hepatic resection assessed by computed scans liver volumetric study at one and three months after PH, size and weight of the resected specimen and operative report

ABG (COHb)

1.54 percentage of Carboxyhemoglobin Interval 0.9 to 2.3

SECONDARY outcome

Timeframe: One month after PH and liver function tests

Measure the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration

Outcome measures

Measure

Intervention Arm n=24 Participants CO and ABG Testing Arm CO Testing Pre/Post Hepatic Resection: Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH ABG Testing Pre/Post Hepatic Resection: Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH CT Evaluations: Analyze the relationship between CO production and the extent of hepatic resection assessed by computed scans liver volumetric study at one and three months after PH, size and weight of the resected specimen and operative report

Volume (ml)

170 ml Standard Deviation 146

Adverse Events

Intervention Arm

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

Dr. Cherif Boutros (Surgical Oncologist)

University of Maryland School of Medicine

Phone: 410-328-7320

Email: cboutros@som.umaryland.edu

Results disclosure agreements

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