The Oslo Study of Clonidine in Elderly Patients With Delirium
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- MDAS (Memorial delirium assessment scale)
研究概览
简要总结
Delirium ("acute confusional state")is characterized by an acute decline in attention and cognition, and is a common clinical syndrome in elderly patients.
The purpose of this randomised, controlled, parallel group pilot trial is to explore superiority of clonidine vs placebo in decreasing delirium in patients diagnosed delirium at the acute geriatric ward.
We will also study the feasibility of oral clonidine in a geriatric ward and effects of clonidine upon a variety of outcomes as a means to design a more definite study later.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient > 65 years old admitted to the Medical department
- •Delirium or subsyndromal delirium diagnosed within the last 48 hours
- •Signed informed consent from patient or relatives
- •Expected cooperation of the patients for the treatment and follow up
排除标准
- •Symptomatic bradycardia, bradycardia due to sick-sinus-syndrome, second- or third- degree AV-block (not treated With pacemaker) or any other reason causing HR <50 bpm at time of inclusion
- •Symptomatic hypotension or orthostatic hypotension, or a systolic BP <120 at the time of inclusion
- •Ischemic stroke within the last 3 months or critical peripheral ischemia
- •Acute coronary syndrome, unstable or severe coronary heart disease (symptoms at minimal physical activity; NYHA 3 and 4) and moderate to severe heart failure (NYHA 3 and 4).
- •A diagnosis of polyneuropathy or pheochromocytoma
- •Renal insufficiency (estimated GFR<30 ml/min according to the MDRD formula).
- •Body weight < 45 kg.
- •Considered as moribund on admission.
- •Not able to take oral medications
- •Current use of tricyclic antidepressants, monoamine reuptake inhibitors or ciclosporin
- •Previously included in this study
- •Adverse reactions to clonidine or excipients (lactose, saccharose)
- •Not speaking or reading Norwegian
- •Any other condition as evaluated by the treating physician
- •Admitted to the ICU
研究组 & 干预措施
Clonidine
Clonidine administered orally:
Day 1/loading doses: 75µg every 3rd hour until maximum 4 doses. Day 2-7/maintenance doses: 75µg BID. Duration of treatment is maximum 7 days.
干预措施: Clonidine (Drug)
Placebo (sugar pill)
Placebo administered orally (identical capsula as for expirimental drug):
Day 1/loading doases: 75µg every 3rd hour until maximum 4 doses. Day 2-7/maintenance doses: 75µg BID. Duration of treatment is maximum 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
MDAS (Memorial delirium assessment scale)
时间窗: Participants will be followed for the duration of hospital stay, an expected average of approximately 2 weeks
次要结局
- Delirium subtype(2 weeks)
- Incidence of "full-scale" delirium(2 weeks)
- Patient distress(2 weeks)
- Side effects of clonidine(4 months)
- Institutionalization(4 months)
- Survival(4 months)
- The use of "rescue medication"(2 weeks)
- Length of hospital stay(Hospital stay)
- Pharmacokinetic response to clonidine(1 week)
- Biomarkers(2 weeks)
- Time-to-first delirium(2 weeks)
- Severity of delirium(2 weeks)
- Cognitive function/ independence(4 months)
- Pharmacodynamic response to clonidine(2 weeks)
研究者
Bjørn Erik Neerland, MD
Medical doctor, PhD student
Oslo University Hospital