A Randomised, Double-blind, Multi-centre Placebo Controlled Trial of Dexmedetomidine for Patients With Agitation and Delirium in the Intensive Care Unit
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 7
- 主要终点
- Ventilator-free hours
研究概览
简要总结
The primary aim of the DahLIA trial is to determine, in patients with ICU-associated delirium and agitation who are otherwise pathophysiologically stable (as defined), the number of ventilator-free hours in the incident ICU admission in the 7 days following commencement of trial medication, in patients randomised to receive dexmedetomidine or placebo while receiving all other aspects of standard care.
The null hypothesis assumes no difference in the median number of ventilator-free hours in this ICU admission in the following 7 days, between patients receiving dexmedetomidine and placebo for ICU-associated agitation and delirium.
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
- •Patients will be eligible for the study if, in the opinion of the treating clinician, they continue to require mechanical ventilation only because their degree of agitation requires such a high dose of sedative medication (midazolam or propofol, the only commonly used specific sedatives in our unit) that extubation is not possible, AND in the opinion of their treating intensivist their agitation is so severe as to make lessening their sedation unsafe.
- •These criteria will be objectively quantified as follows:
- •they have required either mechanical restraint and/or anti-delirium or sedative medication in the 4 hours prior to seeking consent AND
- •their Confusion Assessment Method for the ICU (CAM-ICU) test is positive for delirium in the 4 hours prior to seeking consent AND
- •their Motor Activity Assessment Scale (MAAS) score is 5 or more in the 4 hours prior to seeking consent, confirming psychomotor agitation AND
- •their SOFA score is less than or equal to 5 in the 4 hours prior to seeking consent, predicting a mortality or around 5%.
排除标准
- •Age less than 18 years old
- •Pregnancy or breastfeeding
- •Advanced dementia (in the premorbid state requiring professional nursing care)
- •Open or closed head injury
- •Death is deemed imminent and inevitable
- •The patient has previously been enrolled in the DahLIA study
- •Patients who could not be extubated, or who would be intubated within the following 48 hours, even if delirium or agitation were corrected. This will include:
- •Patients receiving high dose opioid for analgesia (not sedation) ( > 40 mg/morphine/day)
- •Patients shortly to return to the operating theatre
- •Patients undergoing repeated invasive procedures, in whom it is desirable to maintain deep sedation
- •Patients likely to require ongoing airway protection or control, or ventilatory support (for example, spinal patients with an inadequate vital capacity)
- •Known allergy to haloperidol or alpha 2 agonists
研究组 & 干预措施
Dexmedetomidine
Dexmedetomidine will be administered intravenously as a maintenance infusion of 0.2 to 1.5 mcg/kg/hour, commencing at 0.5 mcg/kg/hour and titrated according to effect, for as long as deemed necessary by the treating physician. Specifically, the study medication may be (as recommended by the manufacturer) continued after extubation, and if discontinued may be restarted at any time up until ICU discharge. The clinician will have the option of using a loading dose of 1.0 mcg/kg IV over 20 minutes, as recommended by the manufacturer.
Bedside nursing staff will adjust drug infusion rates as necessary, in consultation with the treating physician, aiming to achieve a Riker Sedation-Agitation Scale 20 score of 4.
干预措施: Dexmedetomidine (Drug)
Saline placebo
An identical syringe to that in the intervention arm, but which does not contain dexmedetomidine, will be provided. The initial rate of infusion and subsequent adjustments will be the same as in the dexmedetomidine group.
干预措施: Saline placebo (Drug)
结局指标
主要结局
Ventilator-free hours
时间窗: 7 days following randomisation
The primary outcome measure for the study will be the number of ventilator-free hours in the incident ICU admission in the 7 days following commencement of trial medication, in patients randomised to receive dexmedetomidine or normal saline placebo while receiving all other aspects of standard care.
次要结局
- %ICU time spent with a satisfactory delirium score(7 days following randomisation)
- Time taken to achieve a satisfactory agitation score(7 days following randomisation)
- %ICU time spent with a satisfactory agitation score(7 days following randomisation)
- Need for supplementary sedative medication(7 days following randomisation)
- Need for mechanical restraint(7 days following randomisation)
- Need for supplementary antipsychotic medication(7 days following randomisation)
- Need for tracheostomy(On hospital discharge, or 6 months (whichever is sooner))
- Acute hospital length of stay(On hospital discharge, or 6 months (whichever is sooner))
- Discharge destination(On hospital discharge, or 6 months (whichever is sooner))
- Time to ICU discharge(On hospital discharge, or 6 months (whichever is sooner))
- Overall ICU length of stay(On hospital discharge, or 6 months (whichever is sooner))
- Time to first extubation(On hospital discharge, or 6 months (whichever is sooner))
- Time taken to achieve a satisfactory sedation score(7 days following randomisation)
- %ICU time spent with a satisfactory sedation score(7 days following randomisation)
- Daily SOFA score(7 days following randomisation)
- ICU mortality(On hospital discharge, or 6 months (whichever is sooner))
- Hospital mortality(On hospital discharge, or 6 months (whichever is sooner))
- Duration and rate of vasopressor support(7 days following randomisation)
- Need for insertion of a new central venous catheter to facilitate vasopressor / inotropic support(7 days following randomisation)
- Requirement for reintubation(On hospital discharge, or 6 months (whichever is sooner))
研究者
GLENN EASTWOOD
Associate Professor
Austin Health