Delirium
Conditions
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.
Interventions
DRUGquetiapine
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).
DRUGplacebo
The placebo is made of 100mg of corn starch which is melted in 10cc water.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of delirium within 14 days after admitting to ICU (Rate) | 14 days after admitting to intensive care unit |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed