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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02297763
Other study ID # YJLSM2014
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received July 4, 2014
Last updated November 18, 2014
Start date March 2015

Study information

Verified date July 2014
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 194
Est. completion date
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 90 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Development of delirium within 14 days after admitting to ICU (Rate) 14 days after admitting to intensive care unit Yes
Secondary Duration of delirium occurring within 14 days after admitting to ICU (Days) 14 days after admitting to ICU Yes
Secondary Length of stay in ICU and hospital (Days) up to 24 weeks No
Secondary 60 days in hospital mortality (Rate) 60 days after admitting to ICU No
Secondary Duration of mechanical ventilation in ICU (Days) 14days after admitting to intensive care unit No
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