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Trial record 10 of 450 for:    QUETIAPINE

Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT02612948
Recruitment Status : Completed
First Posted : November 24, 2015
Last Update Posted : November 24, 2015
Sponsor:
Information provided by (Responsible Party):
Brian Daley, University of Tennessee Graduate School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Psychomotor Agitation Drug: Quetiapine Phase 4

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients
Study Start Date : November 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
No Intervention: Standard Care
Standard care for delerium
Active Comparator: Quetiapine
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.
Drug: Quetiapine
escalating dose to prevent delerium.
Other Name: Seroquel




Primary Outcome Measures :
  1. Incidence of delerium [ Time Frame: One year ]
    ICU length of stay



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612948


Locations
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United States, Tennessee
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37922
Sponsors and Collaborators
University of Tennessee Graduate School of Medicine
Investigators
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Principal Investigator: Brian Daley University General Surgeons, P.C.

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Responsible Party: Brian Daley, Professor, University of Tennessee Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT02612948     History of Changes
Other Study ID Numbers: 3709
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Quetiapine Fumarate
Delirium
Psychomotor Agitation
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Psychomotor Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs