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Signs and Symptoms of Opioid-associated Iatrogenic Withdrawal in Critically Ill Adults (SOWA-ICU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435614
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Marc M. Perreault, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
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.

Condition or disease Intervention/treatment
Substance Withdrawal Syndrome Drug: Opioids

Detailed Description:

Objectives:

  1. 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.
  2. To determine if a change in serum cortisol is associated with the presence of OIWS.

Hypotheses:

  1. Considering our first objective is purely descriptive, no hypothesis can be stated.
  2. 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.

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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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.
Drug: 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.
Other Names:
  • Analgesics
  • Narcotics




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Mechanically ventilated adult ICU patients receiving continuous or regular intermittent opioids for more than 72 hours.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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Canada, Quebec
McGill University Health Centre
Montréal, Quebec, Canada, H4A3J1
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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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
Publications:
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Responsible Party: Marc M. Perreault, Pharmacist, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT03435614    
Other Study ID Numbers: 2018-4305
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marc M. Perreault, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Opioid
Withdrawal
Critically ill adults
Cortisol
Additional relevant MeSH terms:
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Critical Illness
Substance Withdrawal Syndrome
Signs and Symptoms
Disease Attributes
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Narcotics
Analgesics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents