跳至主要内容
临床试验/NCT01316965
NCT01316965终止不适用

CONFUCIUS Study : Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2011年4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
终止
入组人数
175
试验地点
1
主要终点
Postoperative delirium rate within 7 days after surgery

研究概览

简要总结

Postoperative delirium is common in the elderly and is associated with a significant increase in mortality, complications, length of hospital stay and admission in long care facility. Several interventions have proved their effectiveness to prevent it but their combination within a multifaceted intervention needs to be assessed using rigorous methodology based on randomized study design. CONFUCIUS trial aims to measure the impact of a multifaceted program on the prevention of postoperative delirium in elderly.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •Male or female subject aged over 75 years
  • •Admission for a scheduled surgery (i.e. all oncologic digestive surgery , ureterostomy, nephrectomy or cystectomy, total hip or knee replacement)
  • •Participation agreement

排除标准

  • •Patients with a progressive and/or poorly managed psychiatric pathology (patients with stabilized depression could be included in the study)

研究组 & 干预措施

multifaceted prevention program

Experimental

干预措施: Multifaceted prevention program HELP(Hospital Elder Life Program) (Behavioral)

usual care

No Intervention

结局指标

主要结局

Postoperative delirium rate within 7 days after surgery

时间窗: 7 days after surgery

次要结局

  • Length of hospital stay(Hospital discharge)
  • Mortality 6 months after surgery(6 months after surgery)
  • Mean delirium intensity within 7 days after surgery(7 days after surgery)
  • Postoperative complications 30 days after surgery incidence(30 days after surgery)
  • Feasibility of the multidisciplinary prevention program(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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