Randomized Double-Blind Clinical Trial to Compare Haloperidol and Non-Pharmacologic Treatment Versus Non-Pharmacologic Treatment and Placebo, in Elderly Hospitalized Patients With Hypoactive Delirium
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in delirium severity
研究概览
简要总结
Haloperidol and Non-Pharmacologic Treatment are recognized treatments for delirium. This study will evaluate which is the best treatment for hypoactive delirium.
详细描述
Background
Delirium is a cognitive disorder that affects attention and other mental functions. It has an acute onset (in hours or days), a fluctuating course and has various conditioning factors such as diseases or withdrawal or intoxication syndromes.
Delirium is a syndrome with multifactorial origin, it commonly presents in elderly patients, with a prevalence of 20%. Delirium develops when basal vulnerability interacts with precipitating factors.
Delirium has three types according to its psychomotor presentation, hyperactive (agitated), hypoactive (tranquil) or mixed. Delirium has serious outcomes, such as prolonged hospitalization (1), cognitive decline and dementia (2,3,4,), posttraumatic stress disorder (5) and a higher mortality (1).
A neurotransmitter imbalance between acetylcholine and dopamine explains delirium symptoms. A dopamine excess has various consequences: hallucinations that are present in 51 %, and delusions, present in up to 43% in hypoactive delirium. These symptoms produce acute stress in patients and caregivers. It is reported that 53.5% of patients recalled the episode of delirium and from these, 55% of them recalled it associated to hallucinations and 95% of them to delusions. Family recalled the event as stressful in 66%, nurses in 65% of those who did not have hallucinations and in 88% of those who had (6).
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who fulfill criteria for delirium according to CAM and DOSS
- •Patients in hospitalization who are not receiving treatment for delirium
- •Patients without treatment with antipsychotics for any other reason
- •Patients whose legally proxy accepts to participate
排除标准
- •Patients who have received pharmacologic treatment for delirium
- •Patients with a corrected QT interval prolongation
- •Patients who receive antipsychotics for any other reason
- •Patients in another age group
- •Patients whose legally proxy does not accept to participate
- •Patients with dementia
- •Patients with Parkinson disease
- •Patients with arrythmias
- •Patients with language or hearing disorders that impede communication
- •Patients hospitalized in the Intensive Care Unit
- •Patients who are receiving benzodiazepines and anticholinergics
- •Patients with dopamine agonists or antagonists
- •Patients who develop a severe neurologic disease
研究组 & 干预措施
Haloperidol and non-pharmacologic
Haloperidol 1.25mg PO q. d. during nine days
Non-pharmacologic measures:
A. Reorientation (i.e., calendar, clocks, familiar objects) B. Glasses and hearing devices for the particular patients needing such aids C. Avoidance of physical restraints D. Limitation of excessive personnel shifts or hospital room E. A tranquil and comfortable environment, especially at night, to avoid interruptions (i.e., dim light, low levels of noise) F. Adequate schedules for medication administration and to take vital signs or medical procedures G. Sleep hygiene (light in the room and movement during the day) H. Avoidance of dehydration I. Avoidance of medications use which are associated with delirium (e.g., psychoactive medications)
干预措施: Haloperidol (Drug)
Haloperidol and non-pharmacologic
Haloperidol 1.25mg PO q. d. during nine days
Non-pharmacologic measures:
A. Reorientation (i.e., calendar, clocks, familiar objects) B. Glasses and hearing devices for the particular patients needing such aids C. Avoidance of physical restraints D. Limitation of excessive personnel shifts or hospital room E. A tranquil and comfortable environment, especially at night, to avoid interruptions (i.e., dim light, low levels of noise) F. Adequate schedules for medication administration and to take vital signs or medical procedures G. Sleep hygiene (light in the room and movement during the day) H. Avoidance of dehydration I. Avoidance of medications use which are associated with delirium (e.g., psychoactive medications)
干预措施: non-pharmacologic measures (Other)
Placebo and non-pharmacologic
Placebo 1.25 mg PO q.d during nine days.
Non-pharmacologic measures:
A. Reorientation (i.e., calendar, clocks, familiar objects) B. Glasses and hearing devices for the particular patients needing such aids C. Avoidance of physical restraints D. Limitation of excessive personnel shifts or hospital room E. A tranquil and comfortable environment, especially at night, to avoid interruptions (i.e., dim light, low levels of noise) F. Adequate schedules for medication administration and to take vital signs or medical procedures G. Sleep hygiene (light in the room and movement during the day) H. Avoidance of dehydration I. Avoidance of medications use which are associated with delirium (e.g., psychoactive medications)
干预措施: Placebo (Other)
Placebo and non-pharmacologic
Placebo 1.25 mg PO q.d during nine days.
Non-pharmacologic measures:
A. Reorientation (i.e., calendar, clocks, familiar objects) B. Glasses and hearing devices for the particular patients needing such aids C. Avoidance of physical restraints D. Limitation of excessive personnel shifts or hospital room E. A tranquil and comfortable environment, especially at night, to avoid interruptions (i.e., dim light, low levels of noise) F. Adequate schedules for medication administration and to take vital signs or medical procedures G. Sleep hygiene (light in the room and movement during the day) H. Avoidance of dehydration I. Avoidance of medications use which are associated with delirium (e.g., psychoactive medications)
干预措施: non-pharmacologic measures (Other)
结局指标
主要结局
Change in delirium severity
时间窗: Participants will be followed at an expected average of nine days
Reduction of 50% from the basal DOSS score
次要结局
- Posttraumatic stress disorder(At 6 months after delirium remission)
- Cerebral blood flow as assessed by transcranial Doppler(At baseline and after 24 h of delirium remission)
- Necessity of additional open label haloperidol doses to control delirium symptoms(Participants will be followed at an expected average of nine days)
- Delirium duration(Participants will be followed at an expected average of nine days)
- Perceived stress(At 24 hours after delirium remission)
- Cognitive impairment as assessed by Montreal Cognitive Assessment (MoCA) <24 points(At 6 months after delirium remission)
- Side effects associated with either intervention(Participants will be followed at an expected average of nine days)