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临床试验/NCT01673776
NCT01673776已完成不适用

Can a Multimodal Approach Improve the Outcome of Patients With a Proximal Femoral Fracture?

Technical University of Munich2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2012年3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
已完成
发起方
入组人数
132
试验地点
2
主要终点
postoperative complications

研究概览

简要总结

This study is designed to compare the outcome of patients with proximal femoral fractures with different perioperative regimes: a group with a multimodal intervention and a control group.

详细描述

Femoral neck fractures constitute both a social and economic challenge. The one year mortality of affected patients amounts to 33%, wherein cardio-vascular complications are the major contributor. It is an objective of the present study to investigate whether a multi-modal perioperative intervention can improve the outcome of these patients.

We plan to carry out a prospective randomized controlled clinical study. Patients with an age above 60 years and proximal femoral fractures (femoral neck fractures or pertrochanteric femoral fractures) are to be included. These are divided into two groups, K and M. General anaesthesia is applied to both groups. In group K a commonly used therapy will be applied whereas in group M an intesified perioperative care will be carried out. The objectives are to provide sufficient analgesia, normotonia and normothermia. Hence, a femoral catheter is applied for pain therapy already preoperatively. Moreover, the pulmonal situation is improved by means of oxygen as needed. The cardiovascular situation is evaluated and optimized by means of extended hemodynamic monitoring both pre- and postoperatively. If needed, the nutrition of the patients is supplemented with highly caloric drinks.

A primary common endpoint is the appearance of postoperative complications. These include cardiovascular, cerebrovascular, pulmonal, renal and surgical complications. Secondary endpoints are mortality, duration of the stay at the hospital and intensive care duration. It is the objective of the study to reduce the probability for at least one postoperative complication from 50% to 25% (α=0,05 and 1-β=0,80). To this end 132 patients would have to be included in the study.

All participants are to be contacted by phone one year after the surgery and their health situation is to be determined.

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
None

入排标准

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

入选标准

  • proximal femoral fracture (femoral neck fracture/ pertrochanteric femoral fracture)
  • Age ≥ 60 years
  • written informed consent

排除标准

  • pathological fracture
  • multiple trauma
  • fracture during a hospital stay due to a different disease

研究组 & 干预措施

K group

No Intervention

commonly used therapy

M group

Experimental

multimodal intervention

干预措施: PulsioFlex® Monitoring (Device)

结局指标

主要结局

postoperative complications

时间窗: The participants will be followed for the duration of hospital stay, an expected average of 14 days

postoperative complications: cardiovascular, cerebrovascular, pulmonal, renal and surgical complications

次要结局

  • duration of the stay at the hospital(1 year)
  • intensive care duration(1 year)
  • mortality(1 year)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (2)

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