Ignite Creation Date:
2024-05-06 @ 2:01 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04195438
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2019-11-20
Brief Title:
Postoperative Heme Oxygenase Induction and Carbon Monoxide Production as a Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Postoperative Heme Oxygenase Induction and Carbon Monoxide Production as a Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy-1301GCC
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will monitor carbon monoxide production in patients undergoing liver resection Carbon monoxide will be checked from arterial blood gas obtained routinely as a part of the postoperative care as well as from the exhaled air of the patient through a CO detector commercially available and used as smokerlyzer helping people to stop smoking The results of the surgical resection will be collected from the patient routinely ordered tests after liver resection including pathology of the resected part of the liver laboratory and radiology tests The study aims to identify the relationship between CO production and recovery after liver resection Results of this study may help in predicting and improving results of liver resection
Detailed Description:
The goal of this proposal is to elucidate the role of HO-1 induction in hepatic regeneration after partial hepatectomy PH There is a growing body of evidence that HO-1 induction through CO production has an important role in cellular protection and regeneration To test this concept we will monitor endogenous CO production in patients who undergo PH and analyze the relationship between CO production and hepatic regeneration Using this approach we will test the following two hypotheses 1 HO-1 induction after PH is proportional to the extent of the surgical resection and 2 failure to appropriately induce HO-1 is associated with impaired hepatic regeneration
Specific Aim 1 To monitor the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection 11 Monitor CO in exhaled air of patients before liver resection at 4 hours and 24 hours after PH 12 Monitor carboxyhemoglobinCOHb in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH 13 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
Specific Aim 2 To analyze the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration after PH 21 Analyze the relationship between CO production and the quantity and quality of hepatic regeneration assessed by computed scans liver volumetric study at one and three months after PH and liver function tests after PH
22 Determine the relation between postoperative liver related morbidity in patients undergoing PH and the extent of postoperative HO-1 induction
Specific Aim 1 To monitor the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection 11 Monitor CO in exhaled air of patients before liver resection at 4 hours and 24 hours after PH 12 Monitor carboxyhemoglobinCOHb in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH 13 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
Specific Aim 2 To analyze the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration after PH 21 Analyze the relationship between CO production and the quantity and quality of hepatic regeneration assessed by computed scans liver volumetric study at one and three months after PH and liver function tests after PH
22 Determine the relation between postoperative liver related morbidity in patients undergoing PH and the extent of postoperative HO-1 induction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None