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临床试验/NCT04517409
NCT04517409已完成不适用

Goal-directed Hemodynamic Therapy Based on Stroke Volume, Pulse Pressure Variation and Continuosus Cardiac Index in Patiens Undergoing Major Hepatic Resection

Castilla-La Mancha Health Service0 个研究点目标入组 45 人开始时间: 2015年11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
45
主要终点
Postoperative complications

研究概览

简要总结

The aim of the study of patients undergoing major hepatic resection was compared standard perioperative (control Group) with hemodinamic management based on PPV, VVS, continuos CO trending and dynamic arterial elastance using radial artery pulse contour analysis (GDHT group). We hypothessized that following this treatment regimen after hepatic resection results in reduced postoperative complications (primary endpoint) and reduced length of hospital stay (secundary endpoint)

详细描述

The study was performed as a prospective randomized trial at the Department of Anesthesiology and Intensive Care Medicine and the Department of Surgery of the Hospital Universitario de Ciudad Real, Spain.Faculty. The study was approved by the local ethical committee. All patients scheduled for hepatic resection of more than two segments were found eligible for study inclusion. Exclusion criteria were: age less than 18, body weight less than 50 kg or more than 150 kg, irregular heart rhythm, severe cardiovascular disease (chronic heart failure, valvular abnormality, cardiomyopathy, etc.), severe liver dysfunction (Child Pugh score B or C). All participants signed informed consent prior study inclusion.

Protocol of the study.

Eligible patients were equally randomized into two study groups: 1) Standard perioperative (Control group ) and 2) hemodinamic management based using radial artery pulse contour analysis (GDHT group). Randomization was performed the day before surgery by the study member responsable for anesthesia delivery using sealed opaque envelope technique stored in non-transparent containers with group allocation in a 1:1 ratio. Only patients were blinded to group allocation. Care providers and investigators could not be blinded due to the presence of the cardiac index trending monitor.

Intraoperative management.

All subjects received balanced anaesthesia, i.v. anaesthetic induction, and neuromuscular relaxants; for pragmatic reasons, their administration was at the discretion of the anaesthetist. Bispectral index monitoring was used to monitor the depth of anaesthesia. Sevoflurane was used for anaesthesia maintenance, with a BIS target range of 40-60. Central venous catheter placement and invasive radial arterial blood pressure monitoring were performed per preference of the anaesthetist.

研究设计

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

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 scheduled for hepatic resection of more than two segments

排除标准

  • age less than 18, body weight less than 50 kg or more than 150 kg, irregular heart rhythm, severe cardiovascular disease (chronic heart failure, valvular abnormality, cardiomyopathy, etc.), severe liver dysfunction (Child Pugh score B or C).

结局指标

主要结局

Postoperative complications

时间窗: 180 days

Pre-defined postoperative complications for each patient were recorded after surgery from the patient record and by visiting patients on the ward by the investigators

次要结局

未报告次要终点

研究者

发起方
Castilla-La Mancha Health Service
申办方类型
Other
责任方
Sponsor

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