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临床试验/NCT04719884
NCT04719884已完成不适用

Fluid Optimisation in Laparoscopic Colorectal Procedures

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年6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
入组人数
60
试验地点
1
主要终点
Duration of hospitalisation

研究概览

简要总结

Goal-directed fluid therapy (GDFT) with hemodynamic monitoring may not be of benefit to all elective patients undergoing major abdominal surgery, particularly those managed in Enhanced Recovery After Surgery protocols (ERAS) setting.

详细描述

Our study compared two groups of patients undergoing elective laparoscopic colorectal surgery: a control group (CG) in which standard haemodynamic monitoring was used, and a study group (SG) in which extended haemodynamic monitoring was applied with appropriate intraoperative interventions. Differences in intraoperative fluid management, hospital stay, and postoperative morbidity were observed.

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, 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
否

入选标准

  • •patients, undergoing elective laparoscopic colorectal surgery

排除标准

  • •Patients with cardiac arrhythmias

研究组 & 干预措施

Control group

No Intervention

Standard perioperative anesthesia management

Study group

Active Comparator

Perioperative extended haemodynamic monitoring of fluid loading, cardiac output and changes of peripheral vascular resistance by analysing the arterial curve was provided by non-invasive haemodynamic monitoring (LIDCO Rapid, Lidco Ltd., United Kingdom).In SG fluid optimisation was performed before pneumoperitoneum and after abdominal desuflation with actions to achieved CI, MAP and SI within 80% of baseline values.

干预措施: Perioperative fluid optimisation (Procedure)

结局指标

主要结局

Duration of hospitalisation

时间窗: 1 month after admission

次要结局

  • Perioperative complications(8 days after surgery)

研究者

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

Alenka Spindler-Vesel

asist prof

University Medical Centre Ljubljana

研究点 (1)

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