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临床试验/NCT03522688
NCT03522688进行中(未招募)4 期

Impact of Dexmedetomidine on Acute Kidney Injury Following Living Donor Liver Transplantation: A Randomized Controlled Study

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2017年7月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
214
试验地点
1
主要终点
acute kidney injury

研究概览

简要总结

Acute kidney injury (AKI) following liver transplantation (LT) is associated with increased costs, morbidity, and mortality. Dexmedetomidine has known to have anti-inflammatory effect and has been shown to ameliorate IRI in several organs. However, the impact of Dexmedetomidine on AKI after LT is not determined yet. Therefore, this study aims to observe the renal protective effects of Dexmedetomidine after LT.

详细描述

Acute kidney injury (AKI) following liver transplantation (LT) has shown a wide range of incidence between 17% and 95% and is associated with increased costs, morbidity, and mortality. The etiology of AKI after LT is multifactorial. Among these factors, renal ischemia-reperfusion injury (IRI) caused by perioperative renal hypoperfusion is considered as one of the most important independent risk factors and recent reports have indicated that IRI is associated with an inflammatory cascade. Dexmedetomidine which is a highly selective agonist of α2-adrenergic receptors has known have anti-inflammatory effect and has been shown to ameliorate IRI in several organs. However, the impact of Dexmedetomidine on AKI after LT is not determined yet. Therefore, this study aims to observe the renal protective effects of Dexmedetomidine after LT.

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
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • living liver transplantation recipients

排除标准

  • preoperative renal dysfunction
  • dual living donor liver transplantation
  • severe cerebral artery disease
  • severe cardio-pulmonary disease

研究组 & 干预措施

control group

Placebo Comparator

The control group was given normal saline by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour

干预措施: Normal saline (Drug)

treatment group

Active Comparator

The treatment group was given dexmedetomidine by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

acute kidney injury

时间窗: 7 days

serum creatinine levels in postoperative 7 days

次要结局

  • delirium(postoperative day 7)
  • graft failure(1 year)
  • lactate level(3 days)
  • early allograft dysfunction(postoperative day 7)
  • duration of mechanical ventilation(up to 1 year)
  • hospital length of stay(up to 1 year)
  • intensive care unit length of stay(up to 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun-Gol Song

Professor

Asan Medical Center

研究点 (1)

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