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临床试验/NCT02518646
NCT02518646已完成不适用

DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,500
试验地点
1
主要终点
Development of ICU delirium

研究概览

简要总结

Currently, two ICU delirium prediction models are available: the PRE-DELIRIC model and the early prediction model (E-PRE-DELRIC). However, the use of these prediction models is not yet implemented as standard in clinical practice, as it is unknown which delirium prediction model can best be used to predict delirium in ICU patients.Therefore the main aim of this study is to compare the performance of the PRE-DELIRIC model and the E-PRE-DELRIC model.

详细描述

Delirium often occurs in ICU patients and is associated with negative consequences, requiring prevention. A prediction model facilitates the identification of those patients at risk for delirium and therefore need prevention the most. At present, two ICU delirium prediction models are available. First the PRE-DELIRIC model was developed. This recently recalibrated model reliably predicts ICU patients' risk for delirium within 24 hours after ICU admission. Because a relevant number of patients develops delirium during the first 24 hours after ICU admission, and prevention ideally should be deployed as soon as possible, the investigators developed the 'early prediction model' (E-PRE-DELIRIC) which reliably predicts delirium immediately after ICU admission. To implement a delirium prediction model in clinical practice, one needs to know which model best can be used. Currently, the use of a delirium prediction model is not implemented as standard in clinical practice, as this information is unavailable. Therefore the main aim of this study is to compare the (predictive and clinical) performance of the PRE-DELIRIC model and the E-PRE-DELRIC model.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • ICU patients aged ≥18 years;
  • Surgical, medical, neurology/neurosurgical, or trauma patients.

排除标准

  • Delirious at ICU admission;
  • Expected ICU stay shorter than 6 hours;
  • Unable to reliably assess ICU delirium due to:
  • sustained coma during entire ICU stay;
  • unable to understand the language spoken;
  • severely mentally disabled;
  • serious receptive aphasia;
  • serious auditory or visual disorders.

结局指标

主要结局

Development of ICU delirium

时间窗: During the first 14 days after ICU admission

Defined as a positive assessment for delirium and/or when a patient is treated with haloperidol or other anti-psychotics for delirium (and unable to be assessed).

次要结局

  • Delirium onset in a specified period(During the first 14 days after ICU admission)
  • Development of delirium(During the first 14 days after ICU admission)
  • Delirium subtype(During the first 14 days after ICU admission)
  • Delirium episodes(During the first 14 days after ICU admission)
  • Delirium duration(During the first 14 days after ICU admission)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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