A Prospective, Multicenter Registry With Targeted Temperature Management After Out-of-hospital Cardiac Arrest in Korea

Therapeutic hypothermia after out-of-hospital cardiac arrest is considered as a standard care. However, optimal candidates, optimal dose, duration, timing of initiation and rate of rewarming is still unknown. The objective of this project is to improve the outcomes for patients after resuscitation from out-of-hospital cardiac arrest treated with therapeutic hypothermia established from the analysis of multicenter registry data.

Study Overview

• Status: Unknown
• Conditions: Out-of-Hospital Cardiac Arrest
• Intervention / Treatment: Other: not provided

• Study Type: Observational
• Enrollment (Anticipated): 1800

Contacts and Locations

• Study Contact: Name: Kyu Nam Park, MD, PhD; Phone Number: 82-2-2258-6301; Email: emsky@catholic.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06591
    • Recruiting
    • Seoul St. Mary's Hospital, The Catholic University of Korea
    • Contact: Kyu Nam Park, MD, PhD; Phone Number: 82-2-2258-6301; Email: emsky@catholic.ac.kr
    • Principal Investigator: Ji Hoon Kim, MD, PhD
    • Principal Investigator: Won Jung Jeong, MD
    • Principal Investigator: Seung Pill Choi, MD, PhD
    • Principal Investigator: Mi Jin Lee, MD, PhD
    • Principal Investigator: Jong-Seok Lee, MD, PhD
    • Principal Investigator: Su Jin Kim, MD, PhD
    • Principal Investigator: Tae Chang Jang, MD, PhD
    • Principal Investigator: Inbyung Kim, MD
    • Principal Investigator: Yong Hwan Kim, MD
    • Principal Investigator: Won Young Kim, MD, PhD
    • Principal Investigator: Jonghwan Jonghwan, MD
    • Principal Investigator: Ji Hwan Lee, MD
    • Principal Investigator: Giwoon Kim, MD
    • Principal Investigator: Wook-jin Choi, MD, PhD
    • Principal Investigator: Joo Suk Oh, MD PhD
    • Principal Investigator: Chul Han, MD, PhD
    • Principal Investigator: Byung Kook Lee, MD, PhD
    • Principal Investigator: Taeoh Jeong, MD, PhD
    • Principal Investigator: Dong Hoon Lee, MD, PhD
    • Principal Investigator: Jin Hong Min, MD
    • Principal Investigator: Gyu Chong Cho, MD, PhD
    • Principal Investigator: Young Hwan Lee, MD
    • Principal Investigator: In Soo Cho, MD
    • Principal Investigator: Je Sung You, MD, PhD
    • Principal Investigator: Changsun Kim, MD. PhD
    • Principal Investigator: Kyoung-Chul Cha, MD
    • Principal Investigator: Soo Hyung Cho, MD. PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients treated with therapeutic hypothermia after out-of-hospital cardiac arrest.

Description

Inclusion Criteria:

• age of older than 18 years
• out-of-hospital cardiac arrest
• comatose mentality after return of spontaneous circulation (ROSC)
• treated with therapeutic hypothermia, regardless of target temperature

Exclusion Criteria:

• suspected or confirmed to cerebrovascular accident
• poor pre-arrest neurologic status (CPC>3)
• patients who are terminally ill or for whom intensive care dose not seem to be appropriate
• Do not attempt resuscitation (DNAR) order
• patients with tympanic membrane temperature below 30 degree celsius on admission

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival		6 months after cardiac arrest
Neurologic Outcome	Cerebral Performance Category (CPC). CPC 1,2 : Good Outcome CPC 3,4,5 : Poor Outcome	6 months after cardiac arrest
Neurologic Outcome	modified Rankin Scale (mRS) mRS 0,1,2, 3 : Good Outcome mRS 4,5,6 : Poor Outcome	after 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival		duration of hospitalization, limit 180 days
neurological outcome	Cerebral Performance Category (CPC). CPC 1,2 : Good Outcome CPC 3,4,5 : Poor Outcome	duration of hospitalization, limit 180 days
neurological outcome	modified Rankin Scale (mRS) mRS 0,1,2, 3 : Good Outcome mRS 4,5,6 : Poor Outcome	duration of hospitalization, limit 180 days
Survival		1 month after cardiac arrest
neurological outcome	Cerebral Performance Category (CPC). CPC 1,2 : Good Outcome CPC 3,4,5 : Poor Outcome	1 month after cardiac arrest
neurological outcome	modified Rankin Scale (mRS) mRS 0,1,2, 3 : Good Outcome mRS 4,5,6 : Poor Outcome	1 month after cardiac arrest

Collaborators and Investigators

• Sponsor: Kyu Nam Park
• Investigators: Principal Investigator: Kyu Nam Park, MD. PhD, Seoul St. Mary's Hospital, The Catholic University of Korea

Publications and helpful links

General Publications

• Oh JH, Lee DH, Cho IS, Youn CS, Lee BK, Wee JH, Cha KC, Chae MK, Shin J; Korean Hypothermia Network Investigators. Association between acute kidney injury and neurological outcome or death at 6 months in out-of-hospital cardiac arrest: A prospective, multicenter, observational cohort study. J Crit Care. 2019 Dec;54:197-204. doi: 10.1016/j.jcrc.2019.08.029. Epub 2019 Aug 28.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Estimate): October 21, 2016
• Last Update Submitted That Met QC Criteria: October 19, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: therapeutic hypothermia
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 2015-P33001-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO