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

Substance Withdrawal Syndrome Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Substance Withdrawal Syndrome
• Syndrome

• NCT number: NCT02318290
• Study type: Observational
• Source: Hopital du Sacre-Coeur de Montreal
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Completion date: December 2015