Signs and Symptoms of Opioid-associated Iatrogenic Withdrawal in Critically Ill Adults (SOWA-ICU)
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|ClinicalTrials.gov Identifier: NCT03435614|
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : February 7, 2019
|Condition or disease||Intervention/treatment|
|Substance Withdrawal Syndrome||Drug: Opioids|
- 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.
- Considering our first objective is purely descriptive, no hypothesis can be stated.
- OIWS is associated with an increase in serum cortisol.
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.
|Study Type :||Observational|
|Actual Enrollment :||29 participants|
|Official Title:||Signs and Symptoms of Opioid-associated Iatrogenic Withdrawal in Critically Ill Adults|
|Actual Study Start Date :||February 26, 2018|
|Actual Primary Completion Date :||September 30, 2018|
|Actual Study Completion Date :||September 30, 2018|
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.
Once an opioid dose reduction of 10% or greater is achieved, a daily assessment will be conducted by a physician using the DSM-5 criteria for opioid withdrawal. In addition, signs and symptoms of withdrawal will be collected daily by a blinded investigator.
- Presence of OIWS according to DSM-5 criteria [ Time Frame: From first day of opioid dose reduction until transfer out of ICU or a maximum of 14 days, including one further assessment post-ICU transfer ]Sign and symptoms of OIWS
- Change in serum cortisol level [ Time Frame: 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435614
|McGill University Health Centre|
|Montréal, Quebec, Canada, H4A3J1|
|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|