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临床试验/NCT03039946
NCT03039946已完成不适用

Automated Closed-Loop Versus Restrictive Fluid Therapy in Abdominal Surgery: a Pilot Randomized Controlled Trial

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Preload independent state

研究概览

简要总结

The aim of this study is to compare hemodynamic variables and outcome in patients undergoing laparoscopic and/or robotic elective abdominal surgery. Patients will receive either an automated closed-loop goal-directed fluid therapy (GDFT) guided by non-invasive flow monitoring or a restrictive fluid therapy of 4ml/kg/h.

详细描述

Perioperative fluid management is a topic of much debate that has intensified over recent years. Studies have shown improved postoperative outcomes with restricted fluid administration in the perioperative period for moderate risk abdominal surgery. They concluded that in patients undergoing elective abdominal surgery, intraoperative restrictive fluid management was associated with a reduction in postoperative morbidity and shortened hospital stay. Current standard practice is a crystalloid based fluid therapy guided by static hemodynamic parameters such as heart rate, blood pressure, and diuresis. However, several studies have criticized this cookbook approach and recommend tailoring management to specific physiologic dynamic endpoints such as stroke volume variation and cardiac output using a flow monitoring device. Our team has demonstrated that the use of a closed-loop system is feasible and allows precise titration of fluid administration in abdominal and vascular surgery using either a minimally or a non-invasive monitoring system.

Goal:

This study compares hemodynamic variables and outcome in patients who will receive either automated closed-loop fluid therapy guided by non-invasive flow monitoring or restrictive fluid therapy of 4ml/kg/h. Both groups consist of the same population undergoing laparoscopic and/or robotic surgery.

Hypothesis

A closed-loop assisted intraoperative GDFT when compared to restrictive fluid therapy will provide better hemodynamic variables.

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
Single (Participant)

入排标准

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

入选标准

  • •Laparoscopic and/or robotic elective abdominal surgery( colorectal, gynecological, urological)

排除标准

  • •Intraoperative invasive monitoring (arterial line)
  • •Open colorectal surgery (laparotomy)
  • •Emergency surgery
  • •Expected intraoperative blood loss greater than 1000ml
  • •Arrhythmia (e.g. atrial fibrillation)

研究组 & 干预措施

Closed-loop GDFT

Experimental

This group consists of patients undergoing laparoscopic and/or robotic abdominal surgery where fluid maintenance with Plasmalyte is carried out using a closed-loop system guided by the Clearsight non-invasive hemodynamic flow monitor.

干预措施: Closed-Loop GDFT (Device)

Restrictive fluid therapy

Active Comparator

This group consists of patients undergoing laparoscopic and/or robotic abdominal surgery where fluid management is based on a restrictive (4ml/kg/h) Plasmalyte infusion.

干预措施: Restrictive Fluid Therapy (Other)

结局指标

主要结局

Preload independent state

时间窗: 6 hours

The percentage intraoperative time spent with stroke volume variation \< 13% and/or cardiac index \> 2.4 L/min/m2

次要结局

  • Number of closed-loop override by the attending anesthesiologist(6 hours)
  • Postoperative complications(up to 90 days after hospitalization)
  • Additional fluids administered intraoperatively(6 hours)
  • Hospital length of stay(up to 90 days post surgery)

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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