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Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients

Primary Purpose

Delirium

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
quetiapine
placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Greater than or equal to 19 years of age, admitting to medical ICU, anticipated to stay more than 72hours

Exclusion Criteria:

  • Female patients who are pregnant or breastfeeding
  • active delirium
  • Received other anti-psychotic drug before attend the study
  • severe bradycardia
  • alcohol intoxication
  • No written consent from the legal representatives
  • Being ill with renal or hepatic failure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    quetiapine

    placebo

    Arm Description

    quetiapine 12.5mg (bwt <50kg ) or 25mg (bwt>= 50kg) study medicine is pulverized to power and melted in 10cc tepid water. The study medicine(quetiapine) will be provided as liquid form.

    The placebo is made of 100mg of corn starch which is melted in 10cc water.

    Outcomes

    Primary Outcome Measures

    Development of delirium within 14 days after admitting to ICU (Rate)

    Secondary Outcome Measures

    Duration of delirium occurring within 14 days after admitting to ICU (Days)
    Length of stay in ICU and hospital (Days)
    60 days in hospital mortality (Rate)
    Duration of mechanical ventilation in ICU (Days)

    Full Information

    First Posted
    July 4, 2014
    Last Updated
    November 18, 2014
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02297763
    Brief Title
    Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    September 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy of low dose quetiapine for the prophylaxis of delirium in critically ill patients in medical intensive care unit.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    194 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    quetiapine
    Arm Type
    Active Comparator
    Arm Description
    quetiapine 12.5mg (bwt <50kg ) or 25mg (bwt>= 50kg) study medicine is pulverized to power and melted in 10cc tepid water. The study medicine(quetiapine) will be provided as liquid form.
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    The placebo is made of 100mg of corn starch which is melted in 10cc water.
    Intervention Type
    Drug
    Intervention Name(s)
    quetiapine
    Intervention Description
    patient body weight <50kg : quetiapine 12.5mg patient body weight >=50kg : quetiapine 25mg quetiapine 12.5mg (bwt <50kg ) or 25mg (bwt>= 50kg) study medicine is pulverized to power and melted in 10cc tepid water. The study medicine(quetiapine) will be provided as liquid form. The study medicine(quetiapine) was provided as liquid form (medicine was pulverized and melted in 10cc water).
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    The placebo is made of 100mg of corn starch which is melted in 10cc water.
    Primary Outcome Measure Information:
    Title
    Development of delirium within 14 days after admitting to ICU (Rate)
    Time Frame
    14 days after admitting to intensive care unit
    Secondary Outcome Measure Information:
    Title
    Duration of delirium occurring within 14 days after admitting to ICU (Days)
    Time Frame
    14 days after admitting to ICU
    Title
    Length of stay in ICU and hospital (Days)
    Time Frame
    up to 24 weeks
    Title
    60 days in hospital mortality (Rate)
    Time Frame
    60 days after admitting to ICU
    Title
    Duration of mechanical ventilation in ICU (Days)
    Time Frame
    14days after admitting to intensive care unit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Greater than or equal to 19 years of age, admitting to medical ICU, anticipated to stay more than 72hours Exclusion Criteria: Female patients who are pregnant or breastfeeding active delirium Received other anti-psychotic drug before attend the study severe bradycardia alcohol intoxication No written consent from the legal representatives Being ill with renal or hepatic failure

    12. IPD Sharing Statement

    Learn more about this trial

    Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients

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