International Big Data Centre in Emergency Medicine | NCT05616416

Studies
International Big Data Centre in Emergency Medicine

NCT05616416

Sponsor

Guangdong Provincial People's Hospital

Status

Recruiting

Last Update Posted

Jul 1, 2026Actual

Enrollment

500,000Estimated

Phase

Not provided

Conditions

Emergency Medicine

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2011Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Nov 7, 2022

First Submission Date that Met QC Criteria

Nov 13, 2022

First Posted Date

Nov 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2026

Last Update Posted Date

Jul 1, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abdelouahab Bellou, Director of Institute of Sciences in Emergency Medicine, Guangdong Provincial People's HospitalPrincipal Investigator

Lead Sponsor

Guangdong Provincial People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All ED Patient		All patients visited the emergency department during the period.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In-hospital Mortality	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 Outcomes

Measure	Description	Time Frame
Number of Adverse Events	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Every patient who ever visited Emergency Department from 2011-2022

Exclusion Criteria:

Patients with missing demographic (age, gender, etc.) and triage data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The study population will be everybody who visited the Emergency Department.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abdelouahab Bellou, MD, PhD, MSc	Contact	+16176693707		abellou402@gmail.com

Overall Officials

Name	Affiliation	Role
Abdelouahab Bellou, MD, PhD, MSc	Guangdong Provincial People's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangdong Provincial People's Hospital	Recruiting	Guangzhou	Guangdong		China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided