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临床试验/NCT02104687
NCT02104687已完成不适用

The Influence of Intraoperative Goal-directed Hemodynamic Therapy Based on Cardiac Index Trending on the Volume of Intraoperatively Administered Fluids and Vasoactive Agents in Comparison to Standard Pressure Monitoring in Patients Undergoing Major Elective Abdominal Surgery

University Hospital Ostrava2 个研究点 分布在 2 个国家目标入组 140 人开始时间: 2014年4月1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
140
试验地点
2
主要终点
Pre-defined postoperative complications for up to 28 days after surgery

研究概览

简要总结

The purpose of the study is to confirm the hypothesis that flow treatment algorithm based on cardiac index trending by transesophageal Dopplerometry would result in reduced complications and reduced length of hospital stay in major abdominal surgery patients, when compared to patients treated with press treatment algorithm.

详细描述

Despite standardisation of intraoperative care provided for risk surgery patients, the preoperative mortality remains higher than expected. The aim of the goal-directed heamodynamic therapy (GDT) is to improve the altered cardiovascular function and to reach the desired intraoperative values of oxygen supply (DO2) and cardiac index (CI). Standard haemodynamic measurements, such as heart rate (HR), mean arterial pressure (MAP) and central venous pressure (CVP) remain relatively unchanged despite reduced blood flow. However, GTD is able to detect early hypo perfusion abnormalities. The aim of goal-directed heamodynamic therapy, based on the titration of fluids and vasoactive drugs to physiological flow-related end points is to reduce perioperative complications, perioperative morbidity and mortality. We hypothesise, that following this treatment regimen results in reduced postoperative complications (primary endpoint) and reduced length of hospital stay (secondary endpoint).

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 21 years of age and above
  • anticipated duration of surgery more than 120 minutes
  • estimated blood loss exceeding more than 15% of blood volume
  • American Society of Anesthesiology (ASA) classification 2 or 3
  • indication for an arterial line and central venous catheter

排除标准

  • pregnant or lactating women
  • age below 21 years of age
  • emergency surgery
  • American Society of Anesthesiology (ASA) classification 1
  • sepsis and septic shock
  • severe cardiac arrhythmias
  • patients with pathology or intervention on oesophagus

结局指标

主要结局

Pre-defined postoperative complications for up to 28 days after surgery

时间窗: 24 months

The followed postoperative complications include infectious, respiratory, cardiovascular, abdominal, renal complications, massive postoperative bleeding and preoperative death.

次要结局

  • The length of hospitalization(24 months)

研究者

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

研究点 (2)

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