Signs and Symptoms of Opioid-associated Iatrogenic Withdrawal in Critically Ill Adults
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 50
Summary
- Conditions
- Substance Withdrawal Syndrome
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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...
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: A prospective multicentre observational study will be carried out in two university-affiliated hospital ICUs (Montreal General Hospital and Royal Victoria Hospital). All mechanically ventilated adult ICU patients receiving regular (continuous or intermittent) opioids for more than 72 hours will be prospectively screened daily for withdrawal symptoms once the opioid dose is reduced by 10% or more. From that moment, daily evaluation by a physician using the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria for opioid withdrawal will be conducted. Concomitantly, signs and symptoms of withdrawal will be collected by an investigator blinded to the DSM-5 assessment. These assessments will continue daily until the patient is transferred out of ICU or a maximum of 14 days and will be repeated once more between day 1 and day 4 post-transfer out of ICU. A serum cortisol will be drawn on the first day of dose reduction by 10% or more (baseline) and will be repeated either after 72 hours or upon patient discharge from the ICU, whichever one occurs first.
Tracking Information
- NCT #
- NCT03435614
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Marie-Soleil Delisle, MSc McGill University Health Centre/Research Institute of the McGill University Health Centre Principal Investigator: Marc M Perreault, PharmD McGill University Health Centre/Research Institute of the McGill University Health Centre Principal Investigator: Marc-Alexandre Duceppe, MSc McGill University Health Centre/Research Institute of the McGill University Health Centre
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