Post-resuscitation Care Registry for Survival From Out-of... | NCT03695718

Studies
Post-resuscitation Care Registry for Survival From Out-of-hospital Cardiac Arrest

NCT03695718

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Feb 18, 2022Actual

Enrollment

1,057Actual

Phase

Not provided

Conditions

Out-Of-Hospital Cardiac Arrest

Interventions

Not provided

Countries

South Korea

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

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 3, 2013Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Jun 8, 2018

First Submission Date that Met QC Criteria

Oct 2, 2018

First Posted Date

Oct 4, 2018Actual

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

Feb 16, 2022

Last Update Posted Date

Feb 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jong Hwan Shin, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
Seoul National University Bundang Hospital	OTHER
SMG-SNU Boramae Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of this study is to construct multi-center post-cardiac arrest care registry that can be used for data warehousing and clinical research.

Detailed Description

This registry prospectively enrolls adults patients survived out-of-hospital cardiac arrest in 3 academic hospital emergency departments.

Registered data can be used for quality control and clinical research to reduce post-cardiac arrest syndrome-related mortality.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,057Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival	One year survival	1-year

Secondary Outcomes

Measure	Description	Time Frame
28-day mortality	Mortality on the 28th day	28-day
28-day CPC	Brain function at 28th day	28-day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 20 years old or older who presents to the ED of the participating hospitals with any of the following criteria:
1. Sustained ROSC from OHCA at pre-hospital level
2. Sustained ROSC from OHCA at the ED of the participating hospitals after ACLS
3. Patients sustained ROSC from OHCA and transferred from other hospital to the ED of the participating hospitals for post-cardiac arrest care

Exclusion Criteria:

Age less than 20 years old
Patients with advanced directives not to deliver aggressive organ supportive management

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with sustained ROSC from OHCA

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jonghwan Shin, MD, PhD	Seoul National University Boramae Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si		13620	South Korea
Seoul National University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D058687	Out-of-Hospital Cardiac Arrest

Ancestor Terms

ID	Term
D006323	Heart Arrest
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided