Signs and Symptoms of Opioid-associated Iatrogenic Withdrawal in Critically Ill Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Description of Signs and Symptoms of OIWS in Patients Who Scored Positive for Withdrawal Syndrome (OIWS) According to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Criteria
研究概览
简要总结
Mechanically ventilated critically ill adults may require prolonged administration of opioids to facilitate ventilator support and maintain comfort. The prolonged use has been associated with withdrawal symptoms upon rapid weaning in critically ill patients, known as the opioid-associated withdrawal syndrome (OIWS). Such withdrawal symptoms are well described in the paediatric population, however there is a lack of information in the adult population. Currently there is no bedside tool to rapidly identify such patients. Recognition of withdrawal symptoms is the basis for the development of an assessment tool to identify patients with OIWS.
详细描述
Objectives:
- To identify specific signs and symptoms of OIWS in mechanically ventilated adult intensive care unit (ICU) patients receiving at least 72 hours of regular opioids at the Montreal General Hospital (MGH) and the Royal Victoria Hospital (RVH) from February to October 2018.
- To determine if a change in serum cortisol is associated with the presence of OIWS.
Hypotheses:
- Considering our first objective is purely descriptive, no hypothesis can be stated.
- OIWS is associated with an increase in serum cortisol.
Methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 requiring mechanical ventilation and receiving continuous or regular intermittent opioids for at least 72 hours.
- •Weaning of at least 10% from previous stable opioid dose. A weaning episode is defined as a ≥ 10% decrease in the total stable opioid dose received over 4 hours for opioid infusions and over 12 hours for intermittent opioid administration.
排除标准
- •Patient for whom consent cannot be obtained
- •Patient and/or family unable to communicate in French or English
- •Patient who is deaf without appropriate hearing aid
- •Imminent and predictable death (< 72 hours) according to medical team
- •Severe brain injury, defined as Glasgow Coma Scale (GCS) score of 8 or less at ICU admission
- •Moderate brain injury, defined as GCS between 9 and 12, with elevated intracranial pressure (ICP > 20 mmHg) which requires ICP monitoring and osmotherapy
- •Acute neurological condition (e.g. status epilepticus, encephalopathy, stroke). If the acute neurological condition resolves within 72 hours, the patient may be included in the study.
- •Substance abuse prior to ICU admission.
- •Chronic alcohol use defined as alcohol consumption of more than 2 drinks/day and/or more than 14 drinks/week for men and 9 drinks/week for women.
- •Chronic use of illicit drugs and amphetamines (except amphetamines taken for therapeutic purposes) defined as a consumption of at least 3 times per week.
- •Chronic use of opioids (e.g. transdermal fentanyl, methadone, hydromorphone, etc.) defined as a consumption of at least 3 times per week.
- •Readmission to the MGH or RVH ICU during the recruitment period (limit of one study entry per patient)
- •Spinal cord injury above the lumbar region
研究组 & 干预措施
Critically ill patients
Mechanically ventilated critically ill adults receiving regular opioids for more than 72 hours will be prospectively followed for the emergence of withdrawal symptoms upon weaning of opioids.
干预措施: Opioids (Drug)
结局指标
主要结局
Description of Signs and Symptoms of OIWS in Patients Who Scored Positive for Withdrawal Syndrome (OIWS) According to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Criteria
时间窗: From first day of opioid dose reduction until transfer out of Intensive care unit (ICU) or a maximum of 14 days, including one further assessment post-ICU transfer
Percentage of daily assessments associated with each of the following signs and symptoms experienced by patients with and without OIWS (Restlessness (Richmond Agitation-Sedation scale = 1), Agitation (RASS \> 1), Anxiety, Hallucinations, Insomnia/sleep disturbance (\< 4 hours of continuous sleep), Mydriasis (Pupil diameter \> 2 mm) and systolic blood pressure (SBP) \> 140 mmHg. These assessments were performed once daily. Note that for the group of patients experiencing IWS, the data on signs and symptoms are limited to the assessment on the day that patients experienced OIWS. The signs and symptoms presented (Restlessness; Agitation; Anxiety, Hallucinations, Insomnia/sleep disturbance; mydriasis; SBP \> 140) were selected based on a \> 15 % absolute difference between both groups which was judged to be clinically significant.
次要结局
- Change in Serum Cortisol Level(Baseline cortisol on first day of opioid dose reduction and on day 3 post-dose reduction, or on day of transfer out of ICU if patient is transferred before day 3.)
研究者
Marc M. Perreault
Pharmacist
McGill University Health Centre/Research Institute of the McGill University Health Centre