CompletedNot Applicable

Opioids Withdrawal Syndrome in Critically Ill Patients: a Multicenter Prospective Cohort Study

Canada54 participantsStarted 2015-01

Plain-language summary

Critically ill patients who are mechanically ventilated may require prolonged administration of sedatives and analgesics. Their prolonged use has been associated with withdrawal symptoms upon rapid weaning in critically ill patients. These withdrawal symptoms may be associated with adverse clinical outcomes. Although well studied in the paediatric population, little is known about the epidemiology, risk factors and optimal screening methods in adults. Studying this problem is essential as we strive to develop proper weaning strategies. Methods: Prospective observational two-center study in critically ill adult patients Objectives: 1) Describe the incidence of iatrogenic withdrawal of sedatives and analgesics in critically ill adult patients and 2) Evaluate the performance of screening tools assessing withdrawal that were developed for the paediatric patient in the adult population.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * intermittent use or continuous infusion opioids for at least 96 hours Exclusion Criteria: * Patient and/or relatives unable to communicate in French or English * Patients unable to communicate (consent form and evaluation) * Patient deaf without appropriate hearing aid * Patients unable to communicate (consent form and evaluation) * Imminent and predictable death 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 mm Hg) who requires ICP monitoring and osmotherapy * Major confounding factors for withdrawal syndrome by causing shivering, sympathetic drive and autonomic disorders * Underlying active neurological condition (status epilepticus, encephalopathy, hypoxia) * Neurological problems are covariates, which would make the assessment of sedation or IWS difficult Patient previously included in the study at any of the two hospitals (readmission to the ICU at a later date during the period of recruitment for the study, limiting to 1 weaning episode per patient) * Thoracic and cervical spinal cord injury * Adrenergic response to pain will be difficult to assess * Unable to assess validated tool: DSM-V, RASS, CAM-ICU * Narcotic * If the underlying neurological condition resolves within the 96 hours, the patient may be included in the study * Substance abuse prior to ICU admission (28…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Opiate withdrawal according to DSM V critieria

Timeframe: From ICU admission to 48 hours post-extubation or a maximum of 14 days passed since the beginning of the initial weaning process

Trial details

NCT IDNCT02318290

SponsorCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-12

View on ClinicalTrials.gov More Substance Withdrawal Syndrome trials