A Randomized Prospective Pilot Study Of Haloperidol In Addition To Standard Sedation In Mechanically Ventilated Patients With Delirium
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Ventilator-free days out of the first 28
研究概览
简要总结
The goal of this study is to determine whether haloperidol reduces the time on the breathing machine in critically ill patients with delirium.
详细描述
Delirium is a frequent end-organ complication of critical illness and is an independent predictor of mortality in mechanically ventilated patients. However, management of delirium is a major therapeutic challenge and it is unknown if current therapies are disease modifying or function only as symptom management. Haloperidol has been demonstrated to reduce delirium in retrospective studies.
This study is a pilot prospective randomized clinical trial in the Denver Health Medical ICU to determine if haloperidol in addition to an evidence-based standard-of-care sedation protocol for the management of delirium results in a shortened duration of intubation and improvements in post-extubation cognitive status. The haloperidol dose is administered using titration-protocol guided by nursing assessment of delirium using the confusion assessment method for the ICU (CAM-ICU). The primary outcome is ventilator-free days out of the first 28, and secondary outcomes include duration of delirium, length and cost of hospitalization, 28-day mortality, usage of other sedatives, serum markers of delirium (neuron-specific enolase and protein S-100B), and cognitive-function scores at the time of ICU discharge, hospital discharge, and six-month follow-up.
The goal of the 20-patient pilot is demonstrating safety of the haloperidol protocol, as evaluated by an independent data-safety monitoring board. Following approval of the DSMB, 122 more patients will be enrolled in the full RCT to achieve power for an 80% chance of detecting a 40% decrease in duration of intubation with P < 0.05.
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
- None
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
- •Mechanically ventilated within 24 hours of arrival to the ICU
- •Delirium as assessed by CAM-ICU within 24 hours of arrival to the ICU
- •Age > 18
排除标准
- •Known allergy to haloperidol or other neuroleptics
- •Neurological injury or trauma
- •< 24 hours after a major operation
- •History of Axis I psychiatric disorder or significant dementia
- •Baseline QTc of > 500 msec or a pacemaker which makes the QTc uninterpretable
- •History of seizure disorder
- •Morbid obesity (> 1kg/cm body weight)
- •Hepatic failure (Child's Class C)
- •Neuromuscular disease (C5 or higher spinal cord injury, ALS, Guillain-Barre Syndrome, and myasthenia gravis)
- •Malignancy or other irreversible disease or condition for which 6 month mortality is estimated to be ≥ 50%
- •Pregnancy (negative pregnancy test required for women of child-bearing potential)
结局指标
主要结局
Ventilator-free days out of the first 28
次要结局
- Duration of delirium
- Length of hospitalization
- Cost of hospitalization
- 28-day mortality
- Usage of other sedatives
- Serum markers of delirium (neuron-specific enolase and protein S-100B)
- Cognitive-function scores at the time of ICU discharge, hospital discharge, and six-month follow-up