A Preliminary Double-Blind Randomized Controlled Trial of Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer Admitted to a Palliative Care Unit
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points
研究概览
简要总结
This randomized phase II trial studies how well haloperidol with or without lorazepam works in reducing confusion, disorientation, and inability to think or remember clearly (delirium) in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Palliative therapy with haloperidol and lorazepam may reduce symptoms of delirium and help patients with advanced cancer live more comfortably. It is not yet known whether lorazepam may be an effective treatment for delirium when given with haloperidol.
详细描述
PRIMARY OBJECTIVES:
I. To compare the effect of single dose lorazepam and placebo as an adjuvant to haloperidol on the intensity of agitation (Richmond Agitation Sedation Scale) over 8 hours.
II. To assess the within-arm effect of single-dose lorazepam or placebo, as an adjuvant agent with haloperidol, on agitation intensity (Richmond Agitation Sedation Scale) over 8 hours in patients admitted to an acute palliative care unit.
SECONDARY OBJECTIVES:
I. To compare the effect of single dose lorazepam and placebo as an adjuvant to haloperidol on (1) delirium related distress in nurses and caregivers, (2) delirium duration, (3) need for rescue doses of neuroleptics, (4) delirium recall, (5) symptom expression (Edmonton Symptom Assessment Scale), (6) communicative capacity, (7) adverse effects, (8) discharge outcomes, and (9) survival in cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, 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
- •PATIENTS:
- •Diagnosis of advanced cancer (defined as locally advanced, metastatic, recurrent, or incurable disease)
- •Admitted to Acute Palliative Care Unit (APCU)
- •Delirium as per the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV- TR) criteria
- •Hyperactive/mixed delirium with RASS >= 2 in the last 24 hours
- •On scheduled haloperidol of =< 8 mg in the last 24 hours
- •Legally authorized representative consent
- •FAMILY CAREGIVERS:
- •Patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner)
- •Age 18 or older
- •At the patient's bedside at least 4 hours each day during patient delirium episode
- •Patients and family caregivers able to communicate in English or Spanish
排除标准
- •History of myasthenia gravis or acute narrow angle glaucoma
- •History of neuroleptic malignant syndrome
- •History of Parkinson's disease or dementia
- •Uncontrolled seizure disorder
- •History of hypersensitivity to haloperidol or benzodiazepine
- •On regular doses of benzodiazepine or chlorpromazine within the past 48 hours
- •Previously documented and persistent corrected QT (QTc) prolongation (> 500 ms)
- •Heart failure exacerbation at the time of enrollment
研究组 & 干预措施
Lorazepam + Haloperidol
Participants given a single dose of lorazepam 3 mg by vein, in addition to a standardized dose of haloperidol 8 mg/day by vein, while in palliative care unit. Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete
干预措施: Questionnaires (Behavioral)
Placebo + Haloperidol
Participants receive placebo, preservative free 0.9% normal saline, by vein plus a standardized dose of haloperidol 8 mg/day by vein, while in palliative care unit. Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete
干预措施: Placebo (Drug)
Lorazepam + Haloperidol
Participants given a single dose of lorazepam 3 mg by vein, in addition to a standardized dose of haloperidol 8 mg/day by vein, while in palliative care unit. Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete
干预措施: Lorazepam (Drug)
Placebo + Haloperidol
Participants receive placebo, preservative free 0.9% normal saline, by vein plus a standardized dose of haloperidol 8 mg/day by vein, while in palliative care unit. Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete
干预措施: Questionnaires (Behavioral)
Lorazepam + Haloperidol
Participants given a single dose of lorazepam 3 mg by vein, in addition to a standardized dose of haloperidol 8 mg/day by vein, while in palliative care unit. Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete
干预措施: Haloperidol decanoate (Drug)
Placebo + Haloperidol
Participants receive placebo, preservative free 0.9% normal saline, by vein plus a standardized dose of haloperidol 8 mg/day by vein, while in palliative care unit. Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete
干预措施: Haloperidol decanoate (Drug)
结局指标
主要结局
Change in Richmond Agitation-Sedation Scale Score (Baseline to 8 hr), Points
时间窗: Baseline to 8 hours
The primary outcome was change in Richmond Agitation-Sedation Scale score from baseline to 8 hours after treatment administration. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.
Absolute Richmond Agitation-Sedation Scale Score at 8 Hour, Points
时间窗: 8 hours
Absolute score of Richmond Agitation-Sedation Scale at 8 hr, points. Richmond Agitation-Sedation Score ranged from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.
次要结局
- Change in Richmond Agitation-Sedation Scale Score From Baseline to 30 Min(Baseline to 30 minutes)
- Number of Participants With Richmond Agitation-Sedation Scale Score >=1 Within 8 hr(Baseline to 8 hours)