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临床试验/NCT02059460
NCT02059460已完成4 期

Perioperative Evaluation of Terlipressin Infusion During Living Donor Liver Transplantation on Incidence of Acute Kidney

National Liver Institute, Egypt1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2013年5月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
25
试验地点
1
主要终点
Development of acute kidney injury

研究概览

简要总结

To study the impact of intra and post-operative Terlipressin infusion on the occurrence of acute kidney injury after LDLT To investigate perioperative Neutrophil Gelatinase Associated Lipocalin (NGAL) changes and study the effect of Terlipressin on NGAL blood levels

详细描述

The study will be conducted after approval of the local ethics and research committee of anesthesia, ICU and pain management of both Faculty of Medicine and Liver Institute, Menoufia University, Egypt. This study will be conducted in Anesthesia Department, National Liver Institute hospital on patients undergoing liver transplantation. They will be simply randomized with closed envelopes into two groups. Terlipressin group and Control group. A written informed consent will be taken from every patient.

Inclusion criteria: Adult living donor liver transplant recipients with no preoperative renal dysfunction Exclusion criteria: patients with renal insufficiency defined as serum creatinine > 2 mg/dl and GFR <60 ml/min by isotope scanning of the kidney.

Anesthetic Technique:

All patients will be monitored by electrocardiography, noninvasive and invasive arterial blood pressure, pulse oximetry, capnography, fraction inspired oxygen concentration (FiO2). After preoxygenation, general anesthesia will be induced with Propofol 2 mg/kg IV, Fentanyl 2 µg/kg IV and Rocronium 0.9 mg/kg IV followed by endotracheal intubation and maintenance with a mixture of air, oxygen 50% with Desflurane. Mechanical ventilation will be adjusted to maintain end-tidal CO2 between 35-40 mmHg. Central venous line will be inserted for monitoring of central venous pressure (CVP) with ultrasonography guidance.

The esophageal Doppler probe will then be inserted orally and positioned approximately 35-40 cm from the teeth (CardioQTM®, Deltex Medical, Chichester, UK). Normothermia (core temperature > 36°C) will be maintained intraoperatively using forced warming air blanket (Bair Hugger®; Arizant, UK).

研究设计

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

入排标准

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

入选标准

  • Adult living donor liver transplant recipients with no preoperative renal dysfunction

排除标准

  • patients with renal insufficiency defined as serum creatinine > 2 mg/dl and GFR <60 ml/min by isotope scanning of the kidney.

研究组 & 干预措施

Terlipressin group

Experimental

Terlipressin group, Terlipressin (Glypressin®, Rentschler biotechnology Gmbh, Erwin, Germany) will be started by continuous infusion at a dose of 1-4 µg/kg/h till day 4 postoperatively

干预措施: Terlipressin (Drug)

Control group

Placebo Comparator

干预措施: placebo (Drug)

结局指标

主要结局

Development of acute kidney injury

时间窗: 5 days postoperatuvely

it is elevation of serum creatinine \>1.5 mg/dL

次要结局

未报告次要终点

研究者

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

Hanaa Rashed

Assistant lecturer of Anesthesia and Intensive Care

National Liver Institute, Egypt

研究点 (1)

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