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Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients

Primary Purpose

Psychomotor Agitation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Quetiapine
Sponsored by
University of Tennessee Graduate School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychomotor Agitation

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • University of Tennessee Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard Care

Quetiapine

Arm Description

Standard care for delerium

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.

Outcomes

Primary Outcome Measures

Incidence of delerium
ICU length of stay

Secondary Outcome Measures

Full Information

First Posted
November 19, 2015
Last Updated
November 21, 2015
Sponsor
University of Tennessee Graduate School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02612948
Brief Title
Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients
Official Title
Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tennessee Graduate School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychomotor Agitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Standard care for delerium
Arm Title
Quetiapine
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Other Intervention Name(s)
Seroquel
Intervention Description
escalating dose to prevent delerium.
Primary Outcome Measure Information:
Title
Incidence of delerium
Description
ICU length of stay
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Daley
Organizational Affiliation
University General Surgeons, P.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States

12. IPD Sharing Statement

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Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients

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