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临床试验/NCT06108362
NCT06108362招募中4 期

Effect of Intraoperative Terlipressin on the Incidence of Early Postoperative Acute Kidney Injury in Liver Transplantation Patients: a Randomized, Double-blind, Placebo-controlled Study

Beijing Tsinghua Chang Gung Hospital1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2023年8月18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
招募中
入组人数
104
试验地点
1
主要终点
Incidence of acute kidney injury after liver transplantation

研究概览

简要总结

The goal of this clinical trial is to evaluate the effect of intraoperative terlipressin on the incidence of early postoperative acute kidney injury in deceased doner liver transplantation. Patients were randomly divided into experimental group and control group by numerical randomization table. The experimental group was injected with terlipressin perioperative and the control group was injected with placebo

详细描述

acute kidney injury is a relatively common complication in patients with liver transplantation. Most centers have established prediction models for acute kidney injury after liver transplantation, but the incidence cannot be reduced through perioperative anesthesia management. As an vasopressin receptor agonist, terlipressin can increase blood pressure and improve kidney perfusion at the same time, and perioperative application may reduce the incidence of postoperative acute kidney injury

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who plan to undergo liver transplantation in our hospital 2) Patients or family members sign informed consent

排除标准

  • Patients <18 years old;② Patients undergoing autologous liver transplantation or combined transplantation;③ Patients with lower extremity artery stenosis;(4) Patients with severe heart disease、lung disease、kidney disease;⑤ Patients with severe lung disease;⑥ Patients who used renal replacement therapy before surgery;⑦ the depth of one kidney from the body surface is greater than 4cm;⑧ Patients treated with terlipressin within 2 weeks before surgery⑨ Patients allergic to terlipressin.

研究组 & 干预措施

experimental group

Experimental

Continuous terlipressin infusion,Use a syringe to dilute to 50ml Infusion speed is 2ug/kg*h, From the beginning to the end of the surgery.

干预措施: Terlipressin (Drug)

control group

Placebo Comparator

Continuous normal saline infusion,Use a syringe to draw 50ml Infusion speed is 4ml/h, From the beginning to the end of the surgery.

干预措施: normal saline (Drug)

结局指标

主要结局

Incidence of acute kidney injury after liver transplantation

时间窗: in 7 days

acute kidney injury diagnostic criteria (2012 edition)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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