Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients

NCT02297763 | Unknown Phase 3 DMC

• 1 other identifier: YJLSM2014
• Study Type: interventional
• Target: 194
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Development of delirium within 14 days after admitting to ICU (Rate)

  14 days after admitting to intensive care unit

Secondary Outcomes (4)

• 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

Study Arms (2)

quetiapine

ACTIVE COMPARATOR

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.

Drug: quetiapine

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

quetiapine DRUG

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).

quetiapine

placebo DRUG

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

placebo

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than or equal to 19 years of age, admitting to medical ICU, anticipated to stay more than 72hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Delirium

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: November 21, 2014
• Study Start: March 1, 2015
• Primary Completion: September 1, 2016
• Last Updated: November 21, 2014

Record last verified: 2014-07