The Effect of Clonidine-enhanced Sedation on Delirium in Ventilated Critically Ill Patients CATAPRES (Confusion and Alpha-Two Agonist Prescription Randomised Efficacy Study)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- CAM-ICU (Confusion Assessment Method for the Intesive Care Unit)
研究概览
简要总结
Rationale: Delirium is highly prevalent in the ICU. GABA-ergic anaesthetics may provoke delirium. Alpha-2-adrenergic agonists may lead to a reduction of the total amount of GABA-ergic anaesthetics and reduction of delirium. There are no large studies proving that this therapy is effective and safe.
Objective: The objective of this study is to compare the effect of clonidine with placebo on the occurrence and duration of delirium in mechanically ventilated ICU patients.
Study design: Prospective randomised double-blind placebo controlled intervention study in 115 patients.
Study population: All patients >18 years old, intubated mechanically ventilated and sedated at inclusion.
Intervention: Clonidine infusion of 0,25 mcg/kg/h added to the standard sedation regimen. Comparison: NaCl 0,9 % infusion as placebo.
Main study parameters/endpoints: The main study parameter is the total number of awake and delirium-free observation periods the first 7 days after randomisation. An observation period is a nursing shift of 8 hours.
详细描述
Rationale: Delirium is highly prevalent in the ICU. It may cause significant morbidity and mortality. One of the factors that may provoke a delirium is the use of GABA-ergic anaesthetics. Recent studies have shown that sedation with alpha-2-adrenergic agonists may lead to a reduction of the total amount of GABA-ergic anaesthetics and reduction of delirium. In clinical practice the alpha-2-adrenergic agent clonidine is used as an add-on sedative in mechanically ventilated patients who suffer from delirium, but there are no large studies proving that this therapy is effective and safe.
Objective: The objective of this study is to compare the effect of clonidine with placebo on the occurrence and duration of delirium in mechanically ventilated ICU patients.
Study design: Prospective randomised double-blind placebo controlled intervention study in 115 patients.
Study population: All patients >18 years old, intubated mechanically ventilated and sedated at inclusion.
Intervention: Clonidine infusion of 0,25 mcg/kg/h added to the standard sedation regimen. Comparison: NaCl 0,9 % infusion as placebo.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intubated and mechanically ventilated, at the start of the study medication.
- •Age > 18 years
排除标准
- •Severe neurotrauma/CVA
- •Severe dementia
- •Inability to speak Dutch or English
- •The use of clonidine during the 96 hours before the start of the study.
- •Bradycardia (<50/min)
- •Severe hypotension (MAP < 65 after volume resuscitation and two vasopressors)
- •Pregnancy
- •Known clonidine intolerance
- •Liver cirrhosis (Child-Pugh Class C)
- •Recent and acute myocardial infarction
- •Severe heart failure (LVEF<30%)
- •Second or third degree AV block
- •Renal insufficiency requiring intermittent haemodialysis (CVVH is permitted)
- •Expected transfer to another hospital
研究组 & 干预措施
Sodium chloride
干预措施: SodiumChloride (Drug)
Clonidine
干预措施: Clonidine (Drug)
结局指标
主要结局
CAM-ICU (Confusion Assessment Method for the Intesive Care Unit)
时间窗: 7 days
The total amount of delirium-free periods during 7 days after randomisation and start of the study medication. An observation period is a period of 8 hours, coinciding with one nursing shift. A delirium-free period is a shift in which the delirium score is negative.
次要结局
- Opiate use(7 days)
- Ventilation free days(7 days)
- Signs of agitation(7 days)
- Sedation free days(7 days)
- Sedative use(7 days)
- Anti-psychotic use(7 days)
研究者
Marieke Zeeman
Principal Investigator
Deventer Ziekenhuis