Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients

Delirium Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02297763
• Other study ID #: YJLSM2014
• 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. 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

• Delirium

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