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Quetiapine in Prevention of Delirium

Primary Purpose

Delirium

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Quetiapine
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with anemia Sedated patients Hypotensive patients Immobilized patients Patients with visual or auditory impairment Exclusion Criteria: Patients or guardians refuse to participate Patients diagnosed with delirium Contraindication for delirium

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Quetiapine

Non pharmacological preventive bundle

Arm Description

The patients with multiple risks for delirium will receive 25 mg/day PO

The patients will only be monitored with application of delirium preventive bundle without pharmacological agent

Outcomes

Primary Outcome Measures

Quetiapine in preventing delirium
The presence of delirium will be monitored among the patients in the two groups using ICU-Confusion Assessment Method 7 score for delirium where a score of (0-2 = no delirium, 3-5 = mild to moderate delirium and a score >5 = severe delirium)

Secondary Outcome Measures

Full Information

First Posted
February 28, 2023
Last Updated
July 6, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05793632
Brief Title
Quetiapine in Prevention of Delirium
Official Title
Role of Quetiapine in the Prevention of ICU Delirium in Elderly Patients at a High Risk
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim is to study the effectiveness of Quetiapine in preventing delirium in the elderly patients with multiple risks for delirium.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quetiapine
Arm Type
Experimental
Arm Description
The patients with multiple risks for delirium will receive 25 mg/day PO
Arm Title
Non pharmacological preventive bundle
Arm Type
No Intervention
Arm Description
The patients will only be monitored with application of delirium preventive bundle without pharmacological agent
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Description
The patients will be randomly divided into two equal groups group Q and group C. Randomization will be done by computer-generated number lists and using opaque sealed envelopes.
Primary Outcome Measure Information:
Title
Quetiapine in preventing delirium
Description
The presence of delirium will be monitored among the patients in the two groups using ICU-Confusion Assessment Method 7 score for delirium where a score of (0-2 = no delirium, 3-5 = mild to moderate delirium and a score >5 = severe delirium)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with anemia Sedated patients Hypotensive patients Immobilized patients Patients with visual or auditory impairment Exclusion Criteria: Patients or guardians refuse to participate Patients diagnosed with delirium Contraindication for delirium
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walid Kamel
Organizational Affiliation
Faculty of medicine, Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Quetiapine in Prevention of Delirium

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