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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opiates | Drug | Mechanically ventilated patients receiving opiates for more than 96 hours will be evaluated for withdrawal symptoms upon weaning of the opiates |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients under mechanical ventilation and receiving regular intermittent use or continuous infusion opioids for at least 96 hours
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital du Sacré-Coeur | Montreal | Quebec | H4J1C5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9559604 | Background | 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. | |
| 18838937 | 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. |
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| ID | Term |
|---|---|
| D013375 | Substance Withdrawal Syndrome |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D053610 | Opiate Alkaloids |
| D000700 | Analgesics |
| D009294 | Narcotics |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
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|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D002492 | Central Nervous System Depressants |