Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
In population of intensive care unit (ICU), most studies compared atypical antipsychotics such as quetiapine with the traditional haloperidol in delirious patients of various forms and etiologies. The role of such agents in patients with hyperactive is not fully understood.
This study compares the effectiveness of quetiapine with haloperidol in treating the hyperactive form of delirium in terms of their effects on morbidity, length of stay in the intensive care unit, and mortality in critically ill patients.
详细描述
A common complication in the intensive care unit (ICU) that has recently been identified is delirium. Defining delirium as a "sudden deterioration in attention, awareness, and cognition, which is not explained by any pre-existing neurocognitive disorder, but because of another medical condition," the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) clarified the definition of delirium.
A dibenzothiazepine derivative with a novel and distinctive pharmacologic profile is quetiapine. The limbic system is overactive in delirium, which is one of its pathophysiologies. By obstructing the mesolimbic dopamine D2 receptors specifically, quetiapine may be able to regulate this hyperactivity.
The objective of this study is to compare the effectiveness of quetiapine with haloperidol in treating the hyperactive form of delirium in terms of their effects on morbidity, length of stay in ICU, and mortality in critically ill patients.
This research will not receive any grants, funding, or financial aid (NOT FUNDED STUDY). Collaborators declare that they have no conflicts of interest.
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
- Double (Participant, Care Provider)
盲法说明
Double blinded trial
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who are diagnosed with hyperactive form of delirium during their ICU stay using CAM-ICU tool (the confusion assessment method for the intensive care unit)
排除标准
- •Suspected substance-induced delirium
- •Previous use of antipsychotics
- •Known allergy or intolerance to the study drugs
- •Pregnancy or breast feeding
- •Acute renal injury
- •Hepatic failure
- •Inability to tolerate oral drugs
研究组 & 干预措施
Quatiapine group (n=50)
Quetiapine (25-50 mg/day) according to their symptoms of agitations.
干预措施: Quatiapine (Drug)
Haloperidol group (n=50)
Haloperidol (1-2 mg/day) according to their symptoms of agitations.
干预措施: Haloperidol (Drug)
结局指标
主要结局
Response rate
时间窗: Day 7
Response rate is defined as a reduction of the DRS-R-98 severity score from its baseline for 50% or more and a DRS-R-98 severity score of 12 or less without relapse
次要结局
- In-hospital mortality(week 6 from enrollment)
- ICU-mortality(week 6 from enrollment)
- Need for MV(week 6 from enrollment)
- ICU stay(week 6 from enrollment)
- Hospital stay(week 6 from enrollment)