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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Jong Hwan Shin，Seoul National University Hospital

Tracking Information

First Submitted Date ^ICMJE

June 8, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

December 3, 2013

Estimated Primary Completion Date

July 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Survival[ Time Frame: 1-year ]

One year survival

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

28-day mortality[ Time Frame: 28-day ]
Mortality on the 28th day
28-day CPC[ Time Frame: 28-day ]
Brain function at 28th day
6-month CPC[ Time Frame: 6-month ]
Brain function at 6-month
1-year CPC[ Time Frame: 1-year ]
Brain function at 1-year
Organ support treatment (mechanical ventilation)[ Time Frame: Hospital discharge (non-survivors) or 1-year (survivors) ]
Mechanical ventilation
Organ support treatment (renal replacement therapy)[ Time Frame: Hospital discharge (non-survivors) or 1-year (survivors) ]
Renal replacement therapy
ICU length of stay[ Time Frame: Hospital discharge (non-survivors) or 1-year (survivors) ]
ICU length of stay
Hospital length of stay[ Time Frame: Hospital discharge (non-survivors) or 1-year (survivors) ]
Hospital length of stay

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational [Patient Registry]

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational [Patient Registry]
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Study Arms

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1000

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 2019

Estimated Primary Completion Date

July 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

20 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Korea, Republic of

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Jong Hwan Shin，Seoul National University Hospital

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

Seoul National University Hospital

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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