Derivation of An In-Hospital Cardiac Arrest Prediction Mo... | NCT04670458

Studies
Derivation of An In-Hospital Cardiac Arrest Prediction Model for Patients in Intensive Care Unit

NCT04670458

Sponsor

Qilu Hospital of Shandong University

Status

Unknown status

Last Update Posted

Dec 17, 2020Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

In-Hospital Cardiac Arrest

Interventions

no intervention

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

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Sep 30, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Nov 26, 2020

First Submission Date that Met QC Criteria

Dec 10, 2020

First Posted Date

Dec 17, 2020Actual

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

Dec 10, 2020

Last Update Posted Date

Dec 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Current studies have shown that hospitalized ICU patients have a high risk of IHCA, with an incidence of about 0.6-7.8%. Early prediction of the occurrence of IHCA in severe patients can provide early intervention, prevent the deterioration of the disease, and reduce the incidence of IHCA. Therefore, researchers wanted to verify the efficacy of MEWS, NEWS, and CART scores in predicting IHCA in ICU inpatients, and to establish an early-warning scoring model that could effectively predict the risk of IHCA occurrence in ICU inpatients during hospitalization.

Detailed Description

Not provided

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

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CA group		Patients with In-Hospital Cardiac Arrest	Other: no intervention
CONTROL group		Patients without In-Hospital Cardiac Arrest	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	CA group CONTROL group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In-Hospital Cardiac Arrest	Cardiac arrest occurs during hospitalization	Day 2

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

CA group

Inclusion Criteria:

Occurrence of IHCA
Hospital stay ≥48h.

Exclusion Criteria:

<14 years
Do Not Resuscitat
Patients hospitalized due to out-of-hospital cardiac arrest
Cardiac arrest occurs during the operation
The patients with implanted cardiac pacemaker suffered cardiac arrest due to instrument malfunction.

CONTROL group

Inclusion Criteria:

Without IHCA
Hospital stay ≥48h

Exclusion Criteria:

<14 years
Leave hospital without medical advice

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients hospitalized in the intensive care unit (ICU, CCU, RICU, EICU, NCU and DICU) of Qilu Hospital of Shandong University from January 1, 2017 to October 31, 2019 were selected.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wentao Sang	Contact	15153187102		752318151@qq.com
Feng Xu	Contact	18560083066		xufengsdu@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Qilu Hospital of Shandong University	Recruiting	Jinan	Shandong	250012	China