A Randomized, Double-blind, Placebo-controlled Study of an Acetylcholinesterase Inhibitor in the Management of Delirium in Hospitalized Patients Aged 75 Years and Over
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Hospital length of stay from randomization to declaration by investigator (MD) that patient can leave acute care
研究概览
简要总结
The aim of this study is to evaluate the efficacy of an anticholinesterase treatment in patients aged 75 and over, hospitalized with delirium.
Study type : Interventional Study design: randomized, double-blind, placebo-controlled study during one month and a 11-month follow-up
详细描述
Delirium affects up to 50% of hospitalized patients aged 75 and over. Delirium increases risk of comorbid illness, hospital length of stay, institutionalization, and death. Patients with diagnosed or undiagnosed cognitive impairment are at risk to develop delirium. In a prospective study, half of elderly patients with delirium seen in the emergency department had cognitive impairment.
Hypothesis: cholinesterase inhibitors reduce duration and severity of delirium
Main objective:
- to assess the efficacy of cholinesterase inhibitors in patients aged 75 and over hospitalized with delirium
Secondary objectives:
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 75 and over
- •Hospitalization for delirium not correlated to surgery for less than 48 hours
- •Patients with delirium requiring the presence of features 1 (acute onset and fluctuation course), 2 (inattention), 3 (disorganized thinking) and 4 (altered level of consciousness) of the Confusion Assessment Model and DRS R-98 > 10
- •Absence of any contraindications to a cholinesterase inhibitor treatment
- •Health insurance affiliation
- •Having signed an informed consent form
- •Caregiver/informant to provide information on patient
排除标准
- •Use of IAchE or memantine medication
- •Contraindication to IAchE medication
- •Frontotemporal dementia
- •Diseases involving the short-term survival
- •Digestive bleeding
- •Ischemic and hemorrhagic stroke related to actual onset (including hemorrhagic contusion)
- •Natremia ≤120 mmol/l at the time of hospitalization
- •Post epileptic confusion
- •Hepato-cellular failure
- •Cardiorespiratory impairment at risk of transfer to intensive care unit
- •Major sensory deficits that could interfere with cognitive assessment (visual and auditory)
- •Not fluent in French
- •Being under guardianship
- •Absence of caregiver/informant to sign informed consent form
研究组 & 干预措施
Rivastigmine transdermal patch
干预措施: Rivastigmine transdermal patch (Drug)
placebo
干预措施: placebo patch (Drug)
结局指标
主要结局
Hospital length of stay from randomization to declaration by investigator (MD) that patient can leave acute care
时间窗: to a maximum of 12 months
次要结局
- Percentage of patients with persistent delirium symptoms (DRS R-98 scale)(at day 30)
- Percentage of patients with persistent delirium symptoms at day 30 (CAM scale)(at day 30)
- Percentage of patients with a dementia diagnosis at 12 months (according to the DSM IV criteria)(at 12 months)