跳至主要内容
临床试验/NCT06984302
NCT06984302招募中不适用

HYPOTENSION PREDICTION INDEX FOR HEMODYNAMIC OPTIMIZATION IN MAJOR VASCULAR SURGERY

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025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
招募中
入组人数
80
试验地点
1
主要终点
time weighted average of mean arterial presure under 65 mmHg

研究概览

简要总结

We will enroll patients scheduled for abdominal aortic aneurysm repair and divide in two groups; in the control group the hemodynamic optimization will be made based on standard cardiovascular parameters showed in the Hemosphere platform. In the interventional group the hemodynamic optimization will be made based on the hypotension prediction index.

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

  • •planned aortic surgery acceptance of written informed consent

排除标准

  • •body mass index > 35 kg/m2
  • •atrial fibrillation
  • •urgent surgery
  • •end-stage renal disease
  • •pregnancy
  • •refusal of the consent

研究组 & 干预措施

proactive group

Experimental

in this group patients will be managed by a predictive hemodynamic algorithm

干预措施: proactive therapy (Other)

control group

No Intervention

drugs and fluids will be given based on mean arterial pressure and stroke volume variation respectively

结局指标

主要结局

time weighted average of mean arterial presure under 65 mmHg

时间窗: at the end of surgery

we will assess the magnitude of intraoperative arterial hypotension

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

RUSSO ANDREA

MD

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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