- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05616416
International Big Data Centre in Emergency Medicine
Institute of Sciences in Emergency Medicine - International Big Data Centre in Emergency Medicine
This observational study aims to use electronic health records to build an International Big Data Centre in Emergency Medicine, within the Institute of Sciences in Emergency Medicine (ISEM) at the Guangdong Provincial People's Hospital. The main questions it seeks to answer are not limited to the following:
- Identify the relationship between Emergency Department Length of Stay (EDLOS), Mortality, and Adverse Events (AE)
- Identify the risk factors associated with high mortality and AE rate among patients who experience prolonged EDLOS
- Other research questions related to emergency medicine, such as building prediction and cluster models for acute diseases
Study Overview
Status
Conditions
Detailed Description
The relationship between the emergency department length-of-stay (EDLOS), mortality, and adverse events (AE) rate remains unclear and underestimated. EDLOS is the time elapsed between the time of arrival and the time of the release of a patient admitted to ED. Mortality is defined as short-term (14 hours, 48 hours, 7 days, 15 days) and 30 days death of patients managed in the ED discharged or admitted. An AE is an event that can result whether from medical mismanagement or happen by accident and causes physical and mental harm to the patient during the stay and remains after leaving. To separate the mismanagement from accidental causes i.e., compliant management but the unfortunate situation or persons, this study will refer to indicators that are objectively measurable and can be compared at different times throughout the patient's stay in the ED.
The hypothesis is that a prolonged stay of the patients in the ED especially without diagnosis or decision of admission is associated with increased mortality and AEs. This project will test this hypothesis through a prospective international multicenter study in contributing to whether a prolonged EDLOS is associated with an increased rate of adverse outcomes.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Abdelouahab Bellou, MD, PhD, MSc
- Phone Number: +16176693707
- Email: abellou402@gmail.com
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China
- Recruiting
- Guangdong Provincial People's Hospital
-
Contact:
- Abdelouahab Bellou, MD
- Phone Number: +16176693707
- Email: abellou402@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Every patient who ever visited Emergency Department from 2011-2022
Exclusion Criteria:
- Patients with missing demographic (age, gender, etc.) and triage data
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
|
All ED Patient
All patients visited the emergency department during the period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
In-hospital Mortality
Time Frame: From date of ED triage until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 month
|
IHM
|
From date of ED triage until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Adverse Events
Time Frame: From date of ED triage until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 month
|
AE
|
From date of ED triage until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Abdelouahab Bellou, MD, PhD, MSc, Guangdong Provincial People's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY-N-2022-105-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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