Post-stroke Delirium in Ischemic Stroke Patients

Sponsor

Jinan University Guangzhou (Other)

Overall Status

Completed

CT.gov ID

NCT06005636

Collaborator

First Affiliated Hospital of Jinan University (Other)

985

Enrollment

Location

19.8

Actual Duration (Months)

49.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to investigate the predictors of post-stroke delirium, develop and validate a nomogram of post-stroke delirium in the ischemic stroke patients.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Diagnostic Test: Test delirium state

Detailed Description

Introduction: Post-stroke delirium (PSD) is associated with unfavorable prognosis. Effectively identifying risk factors of PSD and predicting PSD is of essential.

Methods: This is a prospective, single-centered, cohort study.

Study Design

Study Type:

Observational

Actual Enrollment :

985 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Risk Factors and Risk Prediction Model for Post-stroke Delirium in Ischemic Stroke Patients

Actual Study Start Date :

Sep 1, 2021

Actual Primary Completion Date :

Sep 10, 2022

Actual Study Completion Date :

Apr 27, 2023

Arms and Interventions

Arm	Intervention/Treatment
with post-stroke delirium ischemic stroke patients with post-stroke delirium	Diagnostic Test: Test delirium state use scale to test whether ischemic stroke patients have post-stroke delirium
without post-stroke delirium ischemic stroke patients without post-stroke delirium	Diagnostic Test: Test delirium state use scale to test whether ischemic stroke patients have post-stroke delirium

Arm

Intervention/Treatment

with post-stroke delirium

ischemic stroke patients with post-stroke delirium

Diagnostic Test: Test delirium state

use scale to test whether ischemic stroke patients have post-stroke delirium

without post-stroke delirium

ischemic stroke patients without post-stroke delirium

Diagnostic Test: Test delirium state

use scale to test whether ischemic stroke patients have post-stroke delirium

Outcome Measures

Primary Outcome Measures

post-stroke delirium [The first week of admission]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

aged ≥18 years old;(2) ischemic stroke, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) scans;(3) patients or their agencies agree to participate in this study.

Exclusion Criteria:

brain dysfunction caused by non-vascular causes such as traumatic brain injury, brain tumor or metastatic brain tumor;(2) history of serious mental illness such as schizophrenia;(3) unable to cooperate to the assessment as deafness, blindness, aphasia, dysarthria;(4) be in coma [Glasgow Coma Scale (GCS)≤8 points] or sedation [Richmond Agitation Sedation Scale (RASS)<-3 points], and do not ameliorate during study;(5) with incomplete data.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the First Affiliated Hospital of Jinan University	Guangzhou	Guangdong	China	510630

Sponsors and Collaborators

Jinan University Guangzhou
First Affiliated Hospital of Jinan University

Investigators

Principal Investigator: Fengxia Yan, Jinan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiaoyan Cai, Ms, Jinan University Guangzhou

ClinicalTrials.gov Identifier:

NCT06005636

Other Study ID Numbers:

KY-2021-106

First Posted:

Aug 22, 2023

Last Update Posted:

Aug 22, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2023