Strategies for Persistent Agitated Delirium in Palliative Care
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- Change in Richmond Agitation Sedation Scale (RASS) score in patients admitted to an acute palliative care unit (APCU)
研究概览
简要总结
This phase II/IIII trial studies how well haloperidol and lorazepam work in controlling symptoms of persistent agitated delirium in patients with cancer that has spread to other places in the body undergoing palliative care. Haloperidol and lorazepam may help in controlling symptoms of agitated delirium in patients with cancer and may lessen any distress that their caregivers may be experiencing.
详细描述
Primary Objectives:
I. To compare the effect of neuroleptic dose escalation, benzodiazepine rotation, combination therapy, and neuroleptic withdrawal on the change in the Richmond Agitation Sedation Scale (RASS) score over 24 hours in patients admitted to an acute palliative care unit (APCU) who do not respond to low-dose haloperidol
Secondary Objectives:
I. To compare the effects of neuroleptic dose escalation, benzodiazepine rotation, combination therapy, and neuroleptic withdrawal on (1) rescue medication use; (2) the proportion of patients in the target RASS range (defined as RASS between -2 and 0) as well as the proportion of patients achieving treatment response (defined as RASS reduction of ≥ 1.5 points); (3) perceived comfort as assessed by caregivers and bedside nurses; (4) delirium-related distress in caregivers and nurses (Delirium Experience Questionnaire); (5) achievement of the proxy comfort goal; (6) symptom expression (Edmonton Symptom Assessment Scale [ESAS]); (7) delirium severity (Memorial Delirium Assessment Scale [MDAS]); (8) adverse effects; and (9) quality of end-of-life care.
II. To identify novel predictive markers of response to haloperidol and lorazepam.
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
- 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
- •[Patients] Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease)
- •[Patients] Admitted to the acute palliative care unit‡
- •[Patients] Delirium as per DSM-5 criteria
- •[Patients] Hyperactive or mixed delirium with RASS ≥1* in the past 24 h despite efforts to treat potential underlying causes
- •[Patients] On scheduled haloperidol for delirium (≤8 mg in the past 24 h) or required ≥4 mg of rescue haloperidol for agitation in the past 24 h
- •[Patients] Age 18 years or older
- •[Caregivers] Patient's spouse, adult child, sibling, parent, other relative, or significant other (partner as defined by patient)
- •[Caregivers] Age 18 years or older
排除标准
- •[Patients] History of myasthenia gravis or acute narrow angle glaucoma
- •[Patients] History of neuroleptic malignant syndrome or active seizure disorder (with seizure episode within the past week)
- •[Patients] History of Parkinson's disease, Alzheimer's or Lewy body dementia
- •[Patients] History of prolonged QTc or QTcF interval (>500 ms)† if documented by most recent ECG within the past month
- •[Patients] History of hypersensitivity to haloperidol or lorazepam
- •[Patients] On scheduled lorazepam within the past 48 h
研究组 & 干预措施
Group I (haloperidol, placebo)
Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.
干预措施: Questionnaire Administration (Other)
Group II (lorazepam, placebo)
Patients receive lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.
干预措施: Lorazepam (Drug)
Group II (lorazepam, placebo)
Patients receive lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.
干预措施: Placebo (Other)
Group I (haloperidol, placebo)
Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.
干预措施: Haloperidol (Drug)
Group I (haloperidol, placebo)
Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.
干预措施: Placebo (Other)
Group I (haloperidol, placebo)
Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.
干预措施: Quality-of-Life Assessment (Other)
Group II (lorazepam, placebo)
Patients receive lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.
干预措施: Quality-of-Life Assessment (Other)
Group II (lorazepam, placebo)
Patients receive lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed and placebo IV every 4 hours and then every hour as needed until discharge from palliative care unit.
干预措施: Questionnaire Administration (Other)
Group III (haloperidol, lorazepam)
Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed until discharge from palliative care unit.
干预措施: Haloperidol (Drug)
Group III (haloperidol, lorazepam)
Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed until discharge from palliative care unit.
干预措施: Lorazepam (Drug)
Group III (haloperidol, lorazepam)
Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed until discharge from palliative care unit.
干预措施: Quality-of-Life Assessment (Other)
Group III (haloperidol, lorazepam)
Patients receive haloperidol IV over 3-15 minutes every 4 hours and then every hour as needed and lorazepam IV over 3-15 minutes every 4 hours and then every hour as needed until discharge from palliative care unit.
干预措施: Questionnaire Administration (Other)
Group IV (placebo, lorazepam)
Patients receive two different placebos IV every 4 hours. Patients then receive placebo IV and lorazepam IV over 3-15 minutes every hour as needed until discharge from palliative care unit.
干预措施: Lorazepam (Drug)
Group IV (placebo, lorazepam)
Patients receive two different placebos IV every 4 hours. Patients then receive placebo IV and lorazepam IV over 3-15 minutes every hour as needed until discharge from palliative care unit.
干预措施: Placebo (Other)
Group IV (placebo, lorazepam)
Patients receive two different placebos IV every 4 hours. Patients then receive placebo IV and lorazepam IV over 3-15 minutes every hour as needed until discharge from palliative care unit.
干预措施: Quality-of-Life Assessment (Other)
Group IV (placebo, lorazepam)
Patients receive two different placebos IV every 4 hours. Patients then receive placebo IV and lorazepam IV over 3-15 minutes every hour as needed until discharge from palliative care unit.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in Richmond Agitation Sedation Scale (RASS) score in patients admitted to an acute palliative care unit (APCU)
时间窗: Baseline to 24 hours
The effect of neuroleptic dose escalation, benzodiazepine rotation, combination therapy, and neuroleptic withdrawal will be compared on the change in the RASS score over 24 hours in patients admitted to an APCU who do not respond to low-dose haloperidol.(RASS between -2 and 0) Will use 2-sided t-tests for four pre-specified paired comparisons, if the required assumptions for this model are met. Non-parametric methods such as Wilcoxon rank-sum test may be used if any assumptions are violated.
次要结局
- Incidence of adverse events(Up to 24 hours)
- Perceived comfort as assessed by caregivers and bedside nurses questionnaire(At 24 hours)
- Quality of end-of-life care: questionnaire(4-8 weeks)
- Proportion of patients in the target RASS range (defined as RASS between -2 and 0) as well as the proportion of patients achieving treatment response (defined as RASS reduction of >= 1.5 points)(At 24 hours)
- Proxy comfort goal level(Up to 24 hours)
- Symptom expression assessed using Edmonton Symptom Assessment Scale(At 24 hours)
- Rescue medication use(At 24 hours)
- To identify novel predictive markers of response to haloperidol and lorazepam.(Up to 24 hours)
- Delirium-related distress in caregivers and nurses assessed using Delirium Experience Questionnaire(At 24 hours)
- Delirium severity assessed using Memorial Delirium Assessment Scale(At 24 hours)