Evaluation Study of a Delirium Prevention Policy Using Prophylactic Haloperidol in Critically Ill Patients With a High Risk for Delirium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Delirium incidence
研究概览
简要总结
Haloperidol is prescribed in high risk ICU patients concerning delirium (50% or more chance to develop delirium detected with the delirium prediction model PRE-DELIRIC, or patients with history of dementia or alcohol abuse)since the delirium protocol is changed and haloperidol is added as a prevention treatment we are gathering information what the effect is on several aspects of delirium
详细描述
Measurement the effect of haloperidol as delirium preventive intervention. Determining effect on:
- delirium incidence in the ICU - different subtypes of delirium - delirium free days in 28 days - days on the ventilator - length of stay on the ICU and In-Hospital - 28-day mortality - incidence of unexpected removal of tubes, and effect between different groups of patients. Safety of haloperidol concerning QT-time, extrapyramidal symptoms.
Data are compared with the data of a historical cohort
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients With Predicted Delirium Chance of >50% or history of dementia or alcohol abuse and treated with haloperidol
排除标准
- •CAM-ICU is Not Applicable
- •Patients Admitted 24hours or Shorter on the ICU, Patients Who Are Delirious Within 24 Hours After ICU Admission
- •patients whereby haloperidol is contra-indicated
结局指标
主要结局
Delirium incidence
时间窗: one year
Delirium is diagnosed as minimal one positive CAM-ICU screening during complete ICU admission. Incidence rate is compared with historical cohort data
次要结局
- duration of delirium days on mechanical ventilator Length of stay in the ICU and in-hospital in-hospital mortality incidence of unplanned removal of tube incidence of delirium subtypes(one year)
- Effect haloperidol on biomarkers(one year)
研究者
Mark van den Boogaard
PhD
Radboud University Medical Center