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Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients

Phase 3
Conditions
Delirium
Interventions
Drug: placebo
Registration Number
NCT02297763
Lead Sponsor
Seoul National University Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
194
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
placeboplaceboThe placebo is made of 100mg of corn starch which is melted in 10cc water.
quetiapinequetiapinequetiapine 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.
Primary Outcome Measures
NameTimeMethod
Development of delirium within 14 days after admitting to ICU (Rate)14 days after admitting to intensive care unit
Secondary Outcome Measures
NameTimeMethod
Duration of delirium occurring within 14 days after admitting to ICU (Days)14 days after admitting to ICU
Length of stay in ICU and hospital (Days)up to 24 weeks
60 days in hospital mortality (Rate)60 days after admitting to ICU
Duration of mechanical ventilation in ICU (Days)14days after admitting to intensive care unit
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