Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients

November 18, 2014 updated by: Seoul National University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

194

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: quetiapine
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of delirium within 14 days after admitting to ICU (Rate)
Time Frame: 14 days after admitting to intensive care unit
14 days after admitting to intensive care unit

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of delirium occurring within 14 days after admitting to ICU (Days)
Time Frame: 14 days after admitting to ICU
14 days after admitting to ICU
Length of stay in ICU and hospital (Days)
Time Frame: up to 24 weeks
up to 24 weeks
60 days in hospital mortality (Rate)
Time Frame: 60 days after admitting to ICU
60 days after admitting to ICU
Duration of mechanical ventilation in ICU (Days)
Time Frame: 14days after admitting to intensive care unit
14days after admitting to intensive care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

July 4, 2014

First Submitted That Met QC Criteria

November 18, 2014

First Posted (Estimate)

November 21, 2014

Study Record Updates

Last Update Posted (Estimate)

November 21, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YJLSM2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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