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Completed

NCT Number: NCT02612948

Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Tennessee Medical Center

Knoxville, Tennessee, 37922, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quetiapine

Drug

escalating dose to prevent delerium.

Other names: Seroquel

Primary outcomes

  1. Incidence of delerium

    Time frame: One year

    ICU length of stay

Sponsors and collaborators

Lead sponsor

University of Tennessee Graduate School of Medicine

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 24, 2015
Registry last updated
Nov 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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