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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03695718
• Collaborator: Seoul National University Bundang Hospital (Other), SMG-SNU Boramae Medical Center (Other)
• Enrollment: 1,057
• Locations: 3
• Actual Duration (Months): 78.9
• Patients Per Site: 352.3
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Out-Of-Hospital Cardiac Arrest

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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 1057 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post-resuscitation Care Registry for Survival From Out-of-hospital Cardiac Arrest
• Actual Study Start Date: Dec 3, 2013
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Jun 30, 2020

Outcome Measures

Primary Outcome Measures

1. Survival [1-year]

   One year survival

Secondary Outcome Measures

1. 28-day mortality [28-day]

   Mortality on the 28th day

2. 28-day CPC [28-day]

   Brain function at 28th day

3. 6-month CPC [6-month]

   Brain function at 6-month

4. 1-year CPC [1-year]

   Brain function at 1-year

5. Organ support treatment (mechanical ventilation) [Hospital discharge (non-survivors) or 1-year (survivors)]

   Mechanical ventilation

6. Organ support treatment (renal replacement therapy) [Hospital discharge (non-survivors) or 1-year (survivors)]

   Renal replacement therapy

7. ICU length of stay [Hospital discharge (non-survivors) or 1-year (survivors)]

   ICU length of stay

8. Hospital length of stay [Hospital discharge (non-survivors) or 1-year (survivors)]

   Hospital length of stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	13620
2	Seoul National University Hospital	Seoul		Korea, Republic of	03080
3	Seoul National University Boramae Hospital	Seoul		Korea, Republic of	07061

Sponsors and Collaborators

• Seoul National University Hospital
• Seoul National University Bundang Hospital
• SMG-SNU Boramae Medical Center

Investigators

• Study Director: Jonghwan Shin, MD, PhD, Seoul National University Boramae Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jong Hwan Shin, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03695718
• Other Study ID Numbers: 16-2013-157
• First Posted: Oct 4, 2018
• Last Update Posted: Feb 18, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest

Study Results

No Results Posted as of Feb 18, 2022