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

February 17, 2016 updated by: David Williamson, Hopital du Sacre-Coeur de Montreal

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objectives of the study are: 1) to describe the incidence of iatrogenic withdrawal of sedatives and analgesics in critically ill adult patients and; 2) Validate screening tools for withdrawal in the adult population.

Hypothesis

  1. Symptoms of iatrogenic benzodiazepines and opioids withdrawal occur commonly in mechanically ventilated patients exposed to high doses and/or prolonged infusions and who are rapidly weaned from these therapies.
  2. The scales for benzodiazepine and narcotic withdrawal detection used in paediatrics population correlate well with the DSM V diagnosis of withdrawal in an adult ICU population
  3. Major risk factors for withdrawal symptoms include longer duration of therapy and higher doses and admission for a medical condition (MICU)

Methods

A prospective multicenter observational study will be carried out in two University-affiliated hospital intensive care units (Hôpital du Sacré-Coeur and Montreal General Hospital). All mechanically ventilated ICU patients receiving continuous infusions of benzodiazepines and/or opioids for more than 96 hours will be prospectively screened daily for withdrawal symptoms by an intensivist. Withdrawal symptoms for opioid and benzodiazepines will be identified using the DSM-V criteria. Patients with moderate to severe head trauma, a severe neurological disease, or prior to admission substance abuse (significant alcohol, illicit or prescription drugs) will be excluded. We will also exclude patients with a regularly prescribed chronic opioid or benzodiazepine use prior to ICU admission. Risk factors for withdrawal including type of agents exposed, dosing, duration of exposure, weaning of agents, organ dysfunction, age, gender, smoking, severity of disease and admission diagnosis will be prospectively collected. The Withdrawal Assessment Tool-1 (WAT-1), a screening tools validated in the paediatric population, will also be administered daily. The criterion validity of this screening tool will be compared to the DSM-V criteria.

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4J1C5
        • Hopital Du Sacre-Coeur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients under mechanical ventilation and receiving regular intermittent use or continuous infusion opioids for at least 96 hours

Description

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)
  • Chronic alcohol use defined as alcohol consumption of more than 2 drinks per day and/or more than 14 drinks per week for men and 9 drinks per week for woman as reported by family or as per patient's medical record

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Critically ill patients
Mechanically ventilated critically ill patients receiveing opiates for more than 96 hours will be prospectively followed for the emergence of withdrawal symptoms upon weaning of opiates
Drug: Opiates
Mechanically ventilated patients receiving opiates for more than 96 hours will be evaluated for withdrawal symptoms upon weaning of the opiates
Other Names:
  • Analgesics
  • Narcotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opiate withdrawal according to DSM V critieria
Time Frame: From ICU admission to 48 hours post-extubation or a maximum of 14 days passed since the beginning of the initial weaning process
Opiate withdrawal as evaluated by an intensivist using DSM V criteria
From ICU admission to 48 hours post-extubation or a maximum of 14 days passed since the beginning of the initial weaning process

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital du Sacre-Coeur de Montreal

Investigators

  • Principal Investigator: David Williamson, Ph.D., Hopital du Sacre-Coeur de Montreal
  • Principal Investigator: Marc Perreaut, Pharm.D., Montreal General Hospital
  • Principal Investigator: Anne Julie Frenette, M.Sc., Hopital du Sacre-Coeur de Montreal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

December 9, 2014

First Submitted That Met QC Criteria

December 12, 2014

First Posted (ESTIMATE)

December 17, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-1112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Substance Withdrawal Syndrome

Clinical Trials on Opiates

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe