Post-stroke Delirium in Ischemic Stroke Patients

August 17, 2023 updated by: Xiaoyan Cai, Jinan University Guangzhou

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

985

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • The First Affiliated Hospital of Jinan University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

ischemic stroke patients were recruited from a Grade 3A hospital in Southern China.

Description

Inclusion Criteria:

  1. 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:

  1. 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.

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

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
post-stroke delirium
Time Frame: The first week of admission
The first week of admission

Collaborators and Investigators

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

Sponsor

Jinan University Guangzhou

Collaborators

First Affiliated Hospital of Jinan University

Investigators

  • Principal Investigator: Fengxia Yan, Jinan University

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 (Actual)

September 1, 2021

Primary Completion (Actual)

September 10, 2022

Study Completion (Actual)

April 27, 2023

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2021-106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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