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Идёт набор NCT05431595

Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy

Фаза II / Фаза III С лечением Delirium Epileptics Neuroleptics

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Haloperidol, Chlorpromazine, Valproate, Placebo.
Кому может быть актуально
Состояния в реестре: Delirium, Epileptics, Neuroleptics. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

To examine the effects of haloperidol, chlorpromazine, valproic acid and placebo, in conjunction with standardized non-pharmacologic interventions, in the first line treatment of agitated delirium in hospitalized patients with cancer. This double-blind, randomized clinical trial aims to provide evidence on various therapeutic options for palliating delirium, thereby reducing delirium-related distress and ultimately alleviating suffering.

Подробное описание

Objectives:

Primary objective:

Compare the effect of scheduled haloperidol, chlorpromazine, valproate and placebo (non-pharmacological interventions alone) on the frequency of breakthrough restlessness over 72 hours in patients with agitated delirium seen by the palliative care consultation team. Our working hypothesis is that haloperidol, chlorpromazine, and valproate will lead to fewer episodes of breakthrough restlessness than placebo.

Secondary Objective #1:

Compare the effects of scheduled haloperidol, chlorpromazine, valproate and placebo on (1) RASS-PAL, (2) need for dose escalation, (3) perceived comfort by caregivers and bedside nurses, (4) delirium severity (Memorial Delirium Assessment Scale), (5) delirium-related distress in caregivers and nurses (Delirium Experience Questionnaire), (6) delirium recall in patients (Delirium Recall Questionnaire), (7) symptom expression (Edmonton Symptom Assessment Scale), (8) adverse effects, and (9) survival. Our working hypothesis is that haloperidol, chlorpromazine, and valproate are superior to placebo (non-pharmacologic interventions alone) in improving delirium-related outcomes.

Secondary Objective #2:

Estimate the efficacy of non-pharmacologic interventions alone on breakthrough restlessness. Our working hypothesis is that patients in the placebo group will require fewer breakthrough doses in the 72 hours after implementation of non-pharmacological interventions

Вмешательства

  • Препарат Haloperidol
    Given by Vein (IV)
  • Препарат Chlorpromazine
    Given by Vein (IV)
  • Препарат Valproate
    Given by Vein (IV)
  • Препарат Placebo
    Given by Vein (IV)

Первичные конечные точки

  • Edmonton Symptom Assessment Scale Questionnaire [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • \[Patients\] Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease)
  • \[Patients\] Seen by palliative care inpatient consultation team
  • \[Patients\] Delirium as per DSM-5 criteria
  • \[Patients\] Hyperactive or mixed delirium with either a rescue medication order or any non-pharmacologic measures (e.g. sitter, restraints) for agitation, restlessness, or delirium
  • \[Patients\] Age 18 years or older
  • \[Patients\] Permission from clinician from primary team to enroll
  • \[Family Caregivers\] Patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner)
  • \[Family Caregivers\] Age 18 years or older

Критерии исключения

  • \[Patients\] On scheduled haloperidol >4 mg/d, chlorpromazine >100 mg/d, or valproate >750 mg/d
  • \[Patients\] History of myasthenia gravis, acute narrow-angle glaucoma, or hepatic encephalopathy as documented in chart
  • \[Patients\] Hepatic dysfunction (unresolved AST or ALT >2.5x ULN, bilirubin >1.5x ULN or INR >1.5 within past month)
  • \[Patients\] History of neuroleptic malignant syndrome as documented in chart
  • \[Patients\] Active seizure disorder within past month as documented in chart
  • \[Patients\] History of Parkinson's disease or dementia as documented in chart
  • \[Patients\] History of prolonged QTc interval (>500 ms) if documented by most recent ECG within the past month
  • \[Patients\] Hypersensitivity to haloperidol, chlorpromazine, or valproate as documented in chart
  • \[Patients\] Pancreatitis within past month as documented in chart
  • \[Patients\] Currently on lamotrigine, phenobarbital, or carbamazepine
  • \[Patients\] Physical signs of impending death such as respiration with mandibular movement and death rattle
  • \[Patients\] Pregnancy as documented in chart
  • \[Patients\] Active COVID-19 infection as documented in chart

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • MD Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT05431595 · 2022-0172 · NCI-2022-05252

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗