跳至主要内容
临床试验/NCT00444262
NCT00444262终止3 期

Study Multicentric, Randomised, in Duplicate Blind Person of the Impact of a Per Operatory Strategy of Optimization of the Cardiac Output on the Forecast of the Old Subjects Operated for Fracture of the Upper End of the Femur " FRACTALE "

Assistance Publique - Hôpitaux de Paris19 个研究点 分布在 1 个国家目标入组 215 人开始时间: 2007年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
入组人数
215
试验地点
19
主要终点
We expect a 30% reduction in the number of per- and post-operative complications observed during hospitalisation in acute care beds in the "optimised" subgroup with respect to "conventional" subgroup. Complications include: death, per-operative

研究概览

简要总结

The aim of this study is to assess whether intra-operative fluid supplementation (to improve tissue perfusion) can reduce the incidence of postoperative complications in elderly patients with hip fracture.

详细描述

Rationale : Hip fracture patients frequently develop postoperative complications that increase their hospital length of stay and the cost of care. These complications are also associated with increased mortality. Perioperative tissue hypoperfusion may participate in the development of postoperative complications. Hypovolemia is secondary to many factors in hip fracture patients (including blood loss, fasting and dehydration) and can result in low cardiac output and tissue hypoperfusion. Two single-center, randomized, double-blind studies have demonstrated that peroperative fluid titration guided by esophageal Doppler measurements of stroke volume could improve patient outcome. Interpretation of these results was that such a stroke volume "optimisation" strategy could help the anesthesiologist give more fluids to his patient and reduce the risk of hypoperfusion without the risk of congestion, thereby reducing postoperative complications and improving patient outcome. We want to test the same hypothesis in a multicenter trial to confirm with a high level of proof the usefulness of this strategy. If previous results are confirmed, this could lead to a change in current anesthetic management of hip fracture patients and potentially have a very important economical impact on health costs.Goals : Primary endpoint is to demonstrate that colloid (Voluven®) titration, guided using esophageal Doppler estimation of stroke volume, during the surgical repair of hip fracture reduces the incidence of postoperative complications (composite criteria). Secondary endpoints in the "optimised group" include : 1) reduced delay to walk without help ; 2) increased number of days " out-of-hospital " at 3 months after the fracture ; and 3) reduced 1-year mortality.

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, Investigator)

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

1

Active Comparator

conventional treatment

干预措施: VOLUVEN and others solute (Drug)

2

Experimental

stroke volume optimisation

干预措施: hemodynamic optimisation guided using esophageal Doppler (Procedure)

结局指标

主要结局

We expect a 30% reduction in the number of per- and post-operative complications observed during hospitalisation in acute care beds in the "optimised" subgroup with respect to "conventional" subgroup. Complications include: death, per-operative

时间窗: during hospitalisation in acute care

次要结局

  • We will check if patients in the "optimised" group have:1) a reduction in the delay to walk without help2) more days " out-of-hospital " at 3 months 3) a reduction in 1-year mortality rate(at 3 months and at one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (19)

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