A Preliminary Double-Blind Randomized Controlled Trial of Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer Admitted to a Palliative Care Unit
概览
- 阶段
- 2 期
- 干预措施
- Lorazepam
- 疾病 / 适应症
- Advanced Cancers
- 发起方
- M.D. Anderson Cancer Center
- 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
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
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. II. To evaluate proportion of patients who consent and are randomized to study however drop out before being treated or before finishing 8-hour Richmond Agitation Sedation Scale (RASS) assessment; and the reasons of drop-outs will be documented and reported. III. To explore the changes in biomarker levels in saliva samples (salivary cortisol, cholinesterase, C-reactive protein, interleukin-1 beta, -6, and -10) over time and in association with delirium severity. IV. To examine the inter-rater reliability of RASS in the Acute Palliative Care Unit (APCU) setting between the bedside nurse and the research nurse at the time of study enrollment. V. To conduct exploratory analyses on RASS as an outcome. VI. To examine the association among rescue medication use, RASS and perceived comfort by the nurses and caregivers. VII. To examine the proportion of patients enrolled onto the delirium trial who achieved control of agitation and did not require the randomized study medication. VIII. To identify patient factors associated with control of agitated delirium. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive lorazepam intravenously (IV) over 1-2 minutes and haloperidol IV every 6 hours or every 1 hour if needed. ARM II: Patients receive placebo IV over 1-2 minutes and haloperidol IV every 6 hours or every 1 hour if needed.
研究者
入排标准
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
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: Lorazepam
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
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
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
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
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
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)