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临床试验/NCT00479011
NCT00479011终止不适用

Intraoperative Fluid Management Based on Arterial Pulse Pressure Variation During High-Risk Surgery

Santa Casa de Passos2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2005年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
33
试验地点
2
主要终点
The primary outcome measure is the duration of postoperative hospital stay.

研究概览

简要总结

Hypovolaemia and tissue hypoperfusion can pass undetected during and after major surgery. The resulting systemic inflammatory response and organ dysfunction, often not clinically apparent for several days, may lead to increased morbidity and mortality and prolonged hospital stay.

In this regard, intraoperative optimization of circulatory status by volume loading has been shown to improve the outcome of patients undergoing high-risk surgery.

Indeed, several reports (1-7) have shown that monitoring and maximizing stroke volume by volume loading (until stroke volume reaches a plateau, actually the plateau of the Frank-Starling curve) during high-risk surgery decreases the incidence of post-operative complications and the length of hospital stay.

Unfortunately, this strategy has required so far the measurement of stroke volume by a cardiac output monitor, as well as a specific training period for the operators (8), and hence is not applicable in many institutions as well as in many countries.

The arterial pulse pressure variation (∆PP) induced by mechanical ventilation is known to be a very accurate predictor of fluid responsiveness, i.e. of the position on the preload/stroke volume relationship (Frank-Starling curve) (9).

By increasing cardiac preload, volume loading induces a rightward shift on the preload/stroke volume relationship and hence a decrease in ∆PP. Patients who have reached the plateau of the Frank-Starling relationship can be identified as patients in whom ∆PP is low (9).

Therefore, the clinical and intraoperative goal of "maximizing stroke volume by volume loading" can be achieved simply by minimizing ∆PP.

We designed the present study to investigate whether monitoring and minimizing ∆PP by volume loading during high-risk surgery may improve post-operative outcome and decrease the duration of post-operative hospital stay.

详细描述

Principal investigator Dr. Marcel Rezende Lopes, Department of Anesthesia and Critical Care, Santa Casa de Misericórdia de Passos, Passos MG, Brazil, marcelrlopes@uol.com.br

Study design Single centre randomized controlled trial

Investigation centre Department of Anesthesia and Critical Care, Santa Casa de Misericórdia de Passos, Passos MG, Brazil

Inclusion criteria

  • medico-surgical pre-operative decision of post-operative ICU admission (because of co-morbidities or/and the surgical procedure)
  • age > 18 yr
  • elective surgery

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single

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

  • Medico-surgical pre-operative decision of post-operative ICU admission (because of co-morbidities or/and the surgical procedure)
  • Age > 18 yr
  • Elective surgery

排除标准

  • No informed consent
  • Cardiac arrhythmias
  • Body mass index > 40
  • Patients undergoing surgery with an open thorax
  • Patients undergoing neurosurgery
  • Enrolment in any other protocol

结局指标

主要结局

The primary outcome measure is the duration of postoperative hospital stay.

时间窗: at days 1,2, and 5, as well as at ICU discharge, and hospital discharge.

次要结局

  • Number of post-operative complications, duration of mechanical ventilation, duration of ICU stay(Post-opertaive days 1,2,5; ICU discharge; hospital discharge)

研究者

发起方
Santa Casa de Passos
申办方类型
Other

研究点 (2)

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