RCT: Trazodone vs Quetiapine vs Placebo for Treating ICU Delirium (TraQ)

Launched by UNIVERSITY OF SOUTHERN CALIFORNIA · Oct 7, 2021

Keywords

ClinConnect Summary

The clinical trial, called TraQ, is looking at how well the medication trazodone works compared to quetiapine and a placebo (a sugar pill) for treating delirium in patients who have undergone surgery and are in the intensive care unit (ICU). Delirium is a serious condition that can cause confusion, agitation, and trouble sleeping. The researchers want to find out if trazodone can help reduce how long patients experience delirium, improve their sleep quality, and potentially lower the risk of complications during their hospital stay.

To be eligible for this trial, participants must be at least 18 years old and have been admitted to the surgical ICU for more than 24 hours. They also need to show signs of delirium, such as being confused or agitated, and require medication to help manage these symptoms. However, some patients may not qualify, especially those with certain medical conditions or who are taking specific medications. If someone is eligible and chooses to participate, they will receive either trazodone, quetiapine, or a placebo and will be monitored closely throughout the study to assess their recovery and any side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. \>=18-years-old
• • 2. Admitted to the surgical ICU for \>24 hours
• • 3. Written informed consent obtained from the patient or their surrogate decision maker.
• • 4. Diagnosis of ICU delirium defined by positive CAM-ICU score AND exhibiting symptomatic delirium (i.e., combative, pulling at lines, a danger to self or others, inability to sleep, hallucinations, etc.), thus, requiring the need for pharmacologic intervention as determined by the attending intensivist
• Exclusion Criteria:
• • 1. Acute alcohol or substance abuse withdrawal symptoms/syndrome (i.e., delirium tremens) requiring treatment/intervention (i.e., implementation of the Clinical Institute Withdrawal Assessment for Alcohol (CIWA) protocol, benzodiazepines, alpha-2 agonist, etc.)
• • 2. Recent torsade de pointes or ventricular arrhythmia
• • 3. Prolonged QTc syndrome AND/OR prolonged QT-interval (QTc\>500 ms on baseline EKG, performed on the day of randomization)
• • 4. Active psychosis
• • 5. Patients taking medications with known interactions with either trazodone and/or quetiapine
• • 6. Acute encephalopathy (i.e., hepatic, uremic, etc.)
• • 7. Seizure disorder
• • 8. myocardial infarction (MI) within the past 30 days
• • 9. Tardive dyskinesia
• • 10. Hyponatremia
• • 11. Terminal state
• • 12. Diagnosis of liver disease
• • 13. Patients who are strict NPO, are a high aspiration risk (defined as frequent nausea/vomiting, ileus, gastric dysmotility disorder, uncontrolled GERD, weakness/deconditioning, diabetes with gastroparesis, not tolerating full tube feeds if being enterally fed (high residual gastric volume \>500 cc), elderly patients with waxing/waning mental status), have dysphagia, and/or have difficulty swallowing capsules as determined by speech therapist
• • 14. Patients who have enteral access such as a small-bore feeding tube, nasogastric or orogastric tube, or gastrostomy/gastrojejunostomy tube (as these patients will need medications crushed in order to administer via the tube, and the capsules used in this study cannot be crushed)
• • 15. Presence of an acute neurologic condition (i.e., acute cerebrovascular accident, intracranial tumor, traumatic brain injury, etc.) on ICU admission. History of stroke or other neurological condition(s) without cognitive impairment is not an exclusion criterion.
• • 16. Pregnancy/lactation
• • 17. History of ventricular arrhythmia including torsade de pointes
• • 18. Allergy/hypersensitivity reaction to trazodone and/or quetiapine
• • 19. Diagnosis of dementia
• • 20. History of neuroleptic malignant syndrome and/or serotonin syndrome
• • 21. Diagnosis of Parkinson's disease or parkinsonism (also referred to as hypokinetic rigidity syndrome)
• • 22. Schizophrenia or other psychotic disorder
• • 23. Patients in whom CAM-ICU cannot be performed to screen for delirium (i.e., acute encephalopathy, mental retardation, vegetative state/coma, deaf, blind, etc.)
• • 24. Inability to speak or understand English
• • 25. Expected to die or transfer out of the ICU within 24 hours
• • 26. Currently enrolled and participating in another interventional study
• • 27. No signed written informed consent by patient or their surrogate decision maker.