- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02297763
Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: quetiapine
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.
|
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). |
Placebo Comparator: placebo
The placebo is made of 100mg of corn starch which is melted in 10cc water.
|
The placebo is made of 100mg of corn starch which is melted in 10cc water.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Development of delirium within 14 days after admitting to ICU (Rate)
Time Frame: 14 days after admitting to intensive care unit
|
14 days after admitting to intensive care unit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of delirium occurring within 14 days after admitting to ICU (Days)
Time Frame: 14 days after admitting to ICU
|
14 days after admitting to ICU
|
Length of stay in ICU and hospital (Days)
Time Frame: up to 24 weeks
|
up to 24 weeks
|
60 days in hospital mortality (Rate)
Time Frame: 60 days after admitting to ICU
|
60 days after admitting to ICU
|
Duration of mechanical ventilation in ICU (Days)
Time Frame: 14days after admitting to intensive care unit
|
14days after admitting to intensive care unit
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Delirium
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Quetiapine Fumarate
Other Study ID Numbers
- YJLSM2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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