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临床试验/NCT04195438
NCT04195438已完成不适用

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

University of Maryland, Baltimore1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年5月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
CO Output (Ppm)

研究概览

简要总结

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.

详细描述

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 1.1 Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH 1.2 Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH 1.3 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 2.1 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.

2.2 Determine the relation between postoperative liver related morbidity in patients undergoing PH and the extent of postoperative HO-1 induction.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients plan to have partial liver resection for primary liver pathology or metastatic disease.
  • •Patients able to comprehend and willing to sign the written consent form.

排除标准

  • •Patients age less than 18
  • •Patients not having pathology proven liver malignancy
  • •Patient not able to comprehend or sign written consent form.

研究组 & 干预措施

Intervention Arm

Other

CO and ABG Testing Arm

干预措施: CO Testing Pre/Post Hepatic Resection (Procedure)

Intervention Arm

Other

CO and ABG Testing Arm

干预措施: ABG Testing Pre/Post Hepatic Resection (Diagnostic Test)

Intervention Arm

Other

CO and ABG Testing Arm

干预措施: CT Evaluations (Diagnostic Test)

结局指标

主要结局

CO Output (Ppm)

时间窗: 24 hours post resection

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

ABG (COHb)

时间窗: 24 hours post resection

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

CO Output (Ppm)

时间窗: Baseline

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

ABG (COHb)

时间窗: Baseline

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

CO Output (Ppm)

时间窗: 4 hours post resection

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

ABG (COHb)

时间窗: 4 hours post resection

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

次要结局

  • Volume (ml)(One month after PH and liver function tests)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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