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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
Sponsor:
Information provided by (Responsible Party):
Marc M. Perreault, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date February 9, 2018
First Posted Date February 19, 2018
Last Update Posted Date February 7, 2019
Actual Study Start Date February 26, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 9, 2018)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 16, 2018)
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. ]
Original Secondary Outcome Measures
 (submitted: February 9, 2018)
Change in serum cortisol level [ Time Frame: Baseline cortisol on first day of opioid dose reduction and on either day 3 post-dose reduction or on day of transfer out of ICU ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Signs and Symptoms of Opioid-associated Iatrogenic Withdrawal in Critically Ill Adults
Official Title Signs and Symptoms of Opioid-associated Iatrogenic Withdrawal in Critically Ill Adults
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Mechanically ventilated adult ICU patients receiving continuous or regular intermittent opioids for more than 72 hours.
Condition Substance Withdrawal Syndrome
Intervention 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
Study Groups/Cohorts 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.
Intervention: Drug: Opioids
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 5, 2019)
29
Original Estimated Enrollment
 (submitted: February 9, 2018)
50
Actual Study Completion Date September 30, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03435614
Other Study ID Numbers 2018-4305
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Marc M. Perreault, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
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
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date February 2019