Pharmacological Management of Delirium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 551
- 试验地点
- 3
- 主要终点
- Days Free of Delirium and Coma
研究概览
简要总结
The purpose of this study is to develop and test the feasibility of using a specific pharmacological protocol to reduce delirium burden among older adults in the Intensive Care Unit (ICU). The study will test the efficacy of a pharmacological intervention in reducing delirium severity and duration as well as length of stay and mortality compared to usual care.
详细描述
In 2005, approximately 2.7 million Americans aged 65 and older spent at least one day in the intensive care unit (ICU), costing Medicare an estimated $27.5 billion. It is estimated that while hospitalized, up to 80% of these older ICU patients had delirium, an acute brain failure that is an independent predictor of morbidity and mortality which often goes unrecognized. Older adults with delirium are more prone to falls, injuries, pressure ulcers and restraints, complications which may also contribute to prolonged ICU and hospital length of stay, higher mortality rates, poorer functional status, limited rehabilitation, increased institutionalization, and higher health care costs. The literature supports treatment with a combination of a reduction in the use of benzodiazepines and anticholinergics and the use of low-dose neuroleptics such as haloperidol. However, there have been no randomized controlled trials evaluating the efficacy of this approach on reducing delirium severity, duration, and complications.
Building upon the e-CHAMP study, ("Enhancing Care for Hospitalized Older Adults With Memory Problems;" see NCT00182832), a recently completed quality improvement project tested the effectiveness of cognitive screening coupled with computerized decision support in reducing delirium and other hospital-related complications among 424 older adults hospitalized on the medical wards, which found that many of the older adults entering the study had already experienced delirium in the ICU prior to their transfer to the wards. This study will test a pharmacologic intervention that allows a more targeted approach to the care of older adults with delirium while still recognizing the clinicians' role in controlling symptoms and providing intensive care.
The hypothesis is that patients in the intervention arm as compared to usual care will have:
- reduced delirium severity, as measured by the Delirium Rating Scale (DRS-R-98), at one week following randomization or hospital discharge
- fewer hospital days with delirium or coma as determined by the Confusion Assessment Method in the ICU (CAM-ICU)
- shorter hospital lengths of stay
- lower ICU, hospital, and 30-day 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 years of age or older
- •Hospitalized on an ICU ward
- •Delirium based on the RASS and the CAM-ICU assessments at any day during ICU stay
- •English speaking
排除标准
- •Admitted directly to a regular non-ICU ward
- •Previously enrolled in the study
- •Not eligible for delirium assessment as determined by RASS scores
- •Prior history of severe mental illness
- •Alcohol-related delirium
- •Pregnant or nursing
- •Have had an aphasic stroke
研究组 & 干预措施
Haloperidol Eligible Intervention
0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
干预措施: Reduced exposure to anticholinergics (Behavioral)
Haloperidol Eligible Intervention
0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
干预措施: Reduced exposure to benzodiazepines (Procedure)
Haloperidol Eligible Intervention
0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
干预措施: Haloperidol (Drug)
Haloperidol Eligible Usual Care
Usual care
干预措施: Usual care (Procedure)
Haldol-Ineligible Arm
Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.
Patients are randomized and will still receive:
reduced exposure to anticholinergics, reduced exposure to benzodiazepines
干预措施: Reduced exposure to anticholinergics (Behavioral)
Haldol-Ineligible Arm
Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.
Patients are randomized and will still receive:
reduced exposure to anticholinergics, reduced exposure to benzodiazepines
干预措施: Reduced exposure to benzodiazepines (Procedure)
Haldol Ineligible Usual Care
Usual Care
干预措施: Usual care (Procedure)
结局指标
主要结局
Days Free of Delirium and Coma
时间窗: Admission through day 8 of stay
次要结局
- Hospital Length of Stay Post Randomization(Participants were followed for the duration of hospital stay, an average of 11 days)
- Mortality(ICU, in-hospital, 30-days post hospitalization)
研究者
MALAZ BOUSTANI
Principal Investigator
Regenstrief Institute, Inc.