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

Out-of-Hospital Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02827422
• Other study ID #: 2015-P33001-00
• Status: Recruiting
• Phase: N/A
• First received: July 5, 2016
• Last updated: October 19, 2016
• Start date: October 2015
• Est. completion date: June 2019

Study information

• Verified date: October 2016
• Source: Seoul St. Mary's Hospital
• Contact: Kyu Nam Park, MD, PhD
• Phone: 82-2-2258-6301
• Email: emsky[@]catholic.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Other:
• not provided

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital, The Catholic University of Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyu Nam Park

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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