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

NCT02318290 | Completed

• 1 other identifier: 2014-1112
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance Withdrawal Syndrome

Keywords

Analgesia; Critical Care; Hypnotics and Sedatives

Outcome Measures

Primary Outcomes (1)

• Opiate withdrawal according to DSM V critieria

  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

Study Arms (1)

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

Interventions

Opiates DRUG

Mechanically ventilated patients receiving opiates for more than 96 hours will be evaluated for withdrawal symptoms upon weaning of the opiates

Also known as: Analgesics, Narcotics

Critically ill patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• intermittent use or continuous infusion opioids for at least 96 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead

Study Sites (1)

Hôpital du Sacré-Coeur

Montreal, Quebec, H4J1C5, Canada

Location

Related Publications (2)

• Cammarano WB, Pittet JF, Weitz S, Schlobohm RM, Marks JD. Acute withdrawal syndrome related to the administration of analgesic and sedative medications in adult intensive care unit patients. Crit Care Med. 1998 Apr;26(4):676-84. doi: 10.1097/00003246-199804000-00015.

  PMID: 9559604 BACKGROUND

• Franck LS, Harris SK, Soetenga DJ, Amling JK, Curley MA. The Withdrawal Assessment Tool-1 (WAT-1): an assessment instrument for monitoring opioid and benzodiazepine withdrawal symptoms in pediatric patients. Pediatr Crit Care Med. 2008 Nov;9(6):573-80. doi: 10.1097/PCC.0b013e31818c8328.

  PMID: 18838937 BACKGROUND

MeSH Terms

Conditions

Substance Withdrawal Syndrome; Agnosia

Interventions

Opiate Alkaloids; Analgesics; Narcotics

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Central Nervous System Depressants

Study Officials

• David Williamson, Ph.D.

  Hopital du Sacre-Coeur de Montréal

  PRINCIPAL INVESTIGATOR

• Marc Perreaut, Pharm.D.

  Montreal General Hospital

  PRINCIPAL INVESTIGATOR

• Anne Julie Frenette, M.Sc.

  Hopital du Sacre-Coeur de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Clinical Professor

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 17, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

CA (1)