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临床试验/NCT01356810
NCT01356810已完成不适用

Manejo Ambiental Profilactico Del Delirium Intrahospitalario

Universidad de Valparaiso1 个研究点 分布在 1 个国家目标入组 287 人开始时间: 2009年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
287
试验地点
1
主要终点
Incidence of Delirium

研究概览

简要总结

Delirium is a complex neuropsychiatric syndrome with an acute onset and fluctuating course which is presented in 15 to 20% of patients admitted to general wards. It is a potentially life - threatening complication which can be prevented. It is the objective of this randomized controlled trial to evaluate whether a multicomponent environmental intervention could reduce the incidence of delirium in a general medical ward.

详细描述

A total of 287 patients 65 years of age or older who had been admitted to a general medicine ward and who were at risk of delirium were studied. Eligible patients were randomized to a multicomponent environmental intervention or standard care. Both groups were well balanced in patients characteristics and followed during the full hospital stay by a group trained in the application of the confusion assessment method to detect incident delirium.

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
Single (Investigator)

入排标准

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

入选标准

  • Above 65 years of age and one of the following:
  • Age above 70 years.
  • Alcoholism
  • Cognitive deficit (Mini mental state examination <24 points)
  • Metabolic disturbance (Hyponatremia, Hypernatremia, Hyperkalemia, Hypokalemia Hyperglycemia or Hypoglycemia)

排除标准

  • Delirium at admission.
  • Admittance to a ward other than general internal medicine.
  • Lack of family support.
  • Informed consent refusal.
  • Hospitalization in a room with more than two beds.

研究组 & 干预措施

Standard Care

Placebo Comparator

Delirium management defined by the attending physician.

干预措施: Standard Care (Other)

Environmental Intervention

Experimental

干预措施: Environmental Intervention (Other)

结局指标

主要结局

Incidence of Delirium

时间窗: Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days)

New episodes of delirium during the hospital stay

次要结局

  • Incidence of Falls(Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Felipe Martinez

Prophylactic Environmental Management of Delirium (MAPDI)

Universidad de Valparaiso

研究点 (1)

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