Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients

Seoul National University

Status and phase: Unknown; Phase 3

Conditions: Delirium

Treatments: Drug: placebo; Drug: quetiapine

Study type: Interventional

Funder types: Other

Identifiers

NCT02297763

YJLSM2014

Details and patient eligibility

About

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.

Enrollment: 194 estimated patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

194 participants in 2 patient groups, including a placebo group

quetiapine

Active Comparator group

Description:

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.

Treatment:

Drug: quetiapine

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo