NCT05793632

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

July 10, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

February 28, 2023

Last Update Submit

July 6, 2023

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

  • 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)

    2 months

Study Arms (2)

Quetiapine

EXPERIMENTAL

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

Drug: Quetiapine

Non pharmacological preventive bundle

NO INTERVENTION

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

Interventions

QuetiapineDRUG

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.

Quetiapine

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with anemia
  • Sedated patients
  • Hypotensive patients
  • Immobilized patients
  • Patients with visual or auditory impairment

You may not qualify if:

  • Patients or guardians refuse to participate
  • Patients diagnosed with delirium
  • Contraindication for delirium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Delirium

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Walid Kamel

    Faculty of medicine, Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 31, 2023

Study Start

March 1, 2023

Primary Completion

April 1, 2023

Study Completion

April 15, 2023

Last Updated

July 10, 2023

Record last verified: 2023-03

Locations

EG(1)