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临床试验/NCT04216407
NCT04216407已完成不适用

The Effects Of Remote Organ Ischemic Preconditioning On Systemic Inflammatory And Glycocalyx Integrity Parameters In Living-Donor Liver Transplantation Patients

Acibadem University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
Intercellular adhesion molecule-1 (ICAM-1)

研究概览

简要总结

Ischemia-reperfusion (IR) injury during liver transplantation is one of the major causes of mortality and morbidity associated with transplantation. Remote organ ischemic preconditioning (RIPC) is one of the most investigated practices to reduce IR injury. In this study, for the first time in the clinic, the effect of RIPC will be evaluated via both systemic inflammation parameters and also parameters showing glycocalyx integrity, on living-donor liver recipients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Patients followed up by Acıbadem Hospital Organ Transplantation Center
  • Patients accepted to participate in the study
  • Older than 18 years of age
  • ASA class III
  • MELD score >12
  • Scheduled for elective liver transplantation surgery from a living donor

排除标准

  • Patients undergoing re-transplantation
  • Under the age of 18 years
  • Patients undergoing emergency surgery
  • Patients with hepatorenal or hepatopulmonary syndrome
  • Patients receiving mechanical ventilation support in the ICU
  • Patients refusing to participate

结局指标

主要结局

Intercellular adhesion molecule-1 (ICAM-1)

时间窗: Postoperative early period (6 hours after intensive care unite admission)

Evaluation of (ICAM-1) level difference between group

Syndecan-1 (SDC-1)

时间窗: Postoperative early period (6 hours after intensive care unite admission)

Evaluation of SDC-1 level difference between groups

Tumor necrosis factor-alpha (TNF-alpha)

时间窗: Postoperative early period (6 hours after intensive care unite admission)

Evaluation of TNF-alpha level difference between groups

Hypoxia-induced factor-1 (HIF-1)

时间窗: Postoperative early period (6 hours after intensive care unite admission)

Evaluation of HIF-1 level difference between groups

Interleukin-8 (IL-8)

时间窗: Postoperative early period (6 hours after intensive care unite admission)

Evaluation of IL-8 level difference between groups

soluble Vascular cell adhesion molecule-1 (sVCAM-1).

时间窗: Postoperative early period (6 hours after intensive care unite admission)

Evaluation of sVCAM-1 level difference between groups

次要结局

  • Liver function tests(7 days after surgery)
  • Length of stay in hospital and intensive care unit(7 days after surgery)
  • Morbidity(7 days after surgery)
  • Mortality(7 days after surgery)

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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