Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients

U

University of Tennessee Graduate School of Medicine

Status and phase

Completed
Phase 4

Conditions

Psychomotor Agitation

Treatments

Drug: Quetiapine

Study type

Interventional

Funder types

Other

Identifiers

NCT02612948
3709

Details and patient eligibility

About

Scheduled, low-dose quetiapine is effective in preventing delirium in high-risk critically ill, trauma/surgical patients. Prophylaxis also reduced ventilator duration and ICU length of stay.

Full description

Objective: To evaluate the efficacy of scheduled quetiapine for delirium prophylaxis in critically ill, trauma/surgical patients identified as high-risk for delirium utilizing a validated prediction model. Design: Prospective, open-label, single-center study. Setting: Trauma/surgical intensive care unit at an academic medical center. Patients: Eighty two adult trauma/surgical patients who were admitted to the intensive care unit and were at high-risk for the development of delirium (PRE-DELIRIC Score ≥50%, past medical history of dementia, past medical history of alcohol misuse, or past medical history of drug abuse). Interventions: Patients were randomized by unit location to receive pharmacologic prophylaxis for delirium (quetiapine 12.5 mg every 12 hours) or no pharmacologic prophylaxis for delirium within forty-eight hours of admission to the intensive care unit. Measurements: The primary end point was the incidence of delirium during admission to the intensive care unit (ICU). Secondary end points included time to onset of delirium, ICU and hospital lengths of stay, ICU and hospital mortality, duration of mechanical ventilation, and adverse events. Delirium was assessed using the confusion assessment method for the intensive care unit.

Enrollment

82 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Trauma/surgical patients admitted to the trauma/surgical ICU

Exclusion criteria

  • sustained RASS of -4/-5 during the complete ICU admission
  • presence of a condition preventing delirium assessment
  • anticipated or known ICU length of stay of less than 48 hours
  • taking antipsychotics prior to admission
  • history of schizophrenia, epilepsy, parkinsonism, or levodopa treatment
  • primary neurologic event/injury with GCS ≤ 9 during the first 48 hours of ICU
  • current treatment with a continuous infusion neuromuscular blocking agent
  • pregnancy
  • screened positive for delirium upon admission to the ICU.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

82 participants in 2 patient groups

Standard Care
No Intervention group
Description:
Standard care for delerium
Quetiapine
Active Comparator group
Description:
Quetiapine therapy was initiated at 12.5 mg twice daily a. After thefirst dose of quetiapine 12.5 mg, the regimen could then be adjusted by the rounding surgeon. If the surgeon felt benefit from receiving a higher dose of quetiapine the dose could then be increased. Quetiapine was discontinued if adverse events (torsades de pointes or other ventricular tachycardias) occurred. All patients receiving at least one dose of quetiapine were included in the final intention-to-treat analyses. All prescribing decisions were left to the discretion of the rounding surgeon and were not mandated as part of the study.
Treatment:
Drug: Quetiapine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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