ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 40
- 主要终点
- 28-day All-cause Mortality
研究概览
简要总结
The purpose of this study is to determine if treating delirious intensive care unit patients with haloperidol improves mortality.
详细描述
Intensive care unit delirium is a serious medical condition that is associated with increased morbidity and mortality. In this study, 304 delirious mechanically ventilated subjects will be randomized to haloperidol 5mg IV every 12 hours or placebo to determine if treatment with haloperidol improves short and long-term mortality.
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
- Triple (Participant, Care Provider, Investigator)
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
- •All adult (>=18 years of age) mechanically ventilated patients admitted to the medical, surgical, trauma, or cardiothoracic ICUs of the UPMC main campus who are expected by the ICU clinical team to require >24 hours of mechanical ventilation
排除标准
- •Baseline QTc >480 milliseconds (ms); history of Parkinson's disease; pregnancy; history of schizophrenia or neurologic disease that would confound the delirium assessment; deafness or inability to understand English or Spanish; extubation prior to enrollment; previously enrolled in this study; patient, family, or attending physician refusal; death before enrollment; treatment with haloperidol within 2 days prior to ICU admission; and prisoners.
研究组 & 干预措施
haloperidol
Once diagnosed as delirious, randomized to haloperidol 5 mg IV
干预措施: haloperidol (Drug)
placebo
once diagnosed as delirious, received 5 mg saline placebo
干预措施: Saline placebo (Other)
结局指标
主要结局
28-day All-cause Mortality
时间窗: Daily
90-day All-cause Mortality
时间窗: 90 Days from enrollment in study
次要结局
- ICU Length of Stay(Daily)
- Duration of Mechanical Ventilation(daily)
研究者
Barb Early
MACRO Clinical Director
University of Pittsburgh