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临床试验/NCT02588716
NCT02588716已完成2 期

Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.

Assiut University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
84
试验地点
1
主要终点
blood loss

研究概览

简要总结

To evaluate the effects of Terlipressin infusion on blood loss & transfusion requirements in cirrhotic patients undergoing major liver resections.

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, 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

  • All patients older than 18 years of age, American Society of Anesthesiology (ASA) classification class I and II and assigned for elective resection of 2 or more liver segments portal hypertension

排除标准

  • Patients with Child-Turcotte-Pugh grade B or C, clinically significant portal hypertension (splenomegaly, thrombocytopenia with platelets < 1011/L, esophageal varices grade 2 or more), Preoperative renal failure (GFR < 50ml/min), heart failure, Bradyarrhythmia (heart rate < 60/min), history of hemorrhagic stroke, Uncontrolled arterial hypertension (Blood pressure >160/100mmHg), and Pregnancy

研究组 & 干预措施

Terlipressin

Active Comparator

Terlipressin will be given at the beginning of surgery as an initial bolus dose of (1 mg over 30 mins) followed by a continuous infusion of 2μg/kg/h to be continued throughout the surgery then gradually withdrawn over 4 hours

干预措施: Terlipressin (Drug)

Control

Placebo Comparator

same volumes of normal saline with the same rate of infusion, throughout the operation then gradually withdrawn over 4 hours.

干预措施: normal saline (Drug)

结局指标

主要结局

blood loss

时间窗: intraoperative period

blood loss in ml

次要结局

  • blood units transfused(intraoperative period)
  • lactate level(at start and end of resection)

研究者

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

Mostafa Samy Abbas

Lecturer, of Anesthesia & ICU, Assiut University

Assiut University

研究点 (1)

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