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临床试验/NCT00852449
NCT00852449终止4 期

Restrictive Versus Liberal Intraoperative Goal-directed Fluid Management During Major Abdominal Surgery:a Prospective Randomized Study

University Hospital, Clermont-Ferrand0 个研究点目标入组 70 人开始时间: 2008年5月1日最近更新:
适应症

试验速览

阶段
4 期
状态
终止
发起方
入组人数
70
主要终点
incidence of intraoperative hypovolemia

研究概览

简要总结

Postoperative organ dysfunction severely affects the prognosis of surgical patients. Despite several trials evaluating restrictive or liberal fluid strategies, the ideal fluid replacement strategy remains controversial. Owing to the risk of altered tissue perfusion, a key trigger of organ dysfunction, the purpose of this study was to compare the influence of restrictive and liberal fluid regimens, using a goal-directed approach, on hypovolemia and postoperative organ dysfunction.

详细描述

Despite several trials evaluating restrictive or liberal fluid strategies, the ideal fluid replacement strategy remains unanswered. Although recent studies suggest that intraoperative fluid restriction may reduce postoperative morbidity and promote faster recovery, extrapolation to individual patients remains difficult. Indeed, whether fluid overload may expose tissue to oedema, impairing oxygenation and wound healing, fluid restriction may, conversely, expose to hypovolemia, which occurs frequently during abdominal surgery, leading to tissue hypoperfusion and organ dysfunction. To date, the restrictive and liberal fluid substitution strategies have not been compared using a goal-directed approach. In addition, recent data suggest that targeting early indicators of hypoperfusion, such as central venous oxygen saturation (ScvO2), which reflects the oxygen delivery/consumption relationship, may be important in the management of patients undergoing major surgery. No data are available on the effects of intraoperative fluid volume replacement strategy on ScvO2 modifications.

The purpose of this study is first to evaluate the influence of restrictive and liberal fluid replacement strategies on both hypovolemia and postoperative organ dysfunction using an oesophageal doppler goal-directed approach (with goal = peak aortic velocity variation and stroke volume optimization) during major abdominal surgery. The second objective is to investigate the effects of fluid loading on ScvO2 modifications.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Triple (Participant, Investigator, 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

入选标准

  • Major intraabdominal surgery

排除标准

  • Age < 18 years
  • Pregnancy
  • Body mass index > 35 kg/m2
  • Emergency surgery
  • Coagulopathy
  • Sepsis or Systemic inflammatory response syndrome (SIRS)
  • Hepatic failure (prothrombin ratio < 50%, factor V < 50%)
  • Contraindication for epidural analgesia

结局指标

主要结局

incidence of intraoperative hypovolemia

时间窗: intraoperative

次要结局

  • postoperative organ failure postoperative complications (included anastomotic leak, perianastomotic abscess)(postoperative)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

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