NCT02827422

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

3.7 years

First QC Date

July 5, 2016

Last Update Submit

October 19, 2016

Conditions

Out-of-Hospital Cardiac Arrest

Keywords

therapeutic hypothermia

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • survival

    duration of hospitalization, limit 180 days

  • neurological outcome

    duration of hospitalization, limit 180 days

  • neurological outcome

    duration of hospitalization, limit 180 days

  • Survival

    1 month after cardiac arrest

  • neurological outcome

    1 month after cardiac arrest

  • +1 more secondary outcomes

Interventions

not providedOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital, The Catholic University of Korea

Seoul, 06591, South Korea

RECRUITING

Related Publications (2)

  • Kim YJ, Kim YH, Youn CS, Cho IS, Kim SJ, Wee JH, Park YS, Oh JS, Lee BK, Kim WY. Different neuroprognostication thresholds of neuron-specific enolase in shockable and non-shockable out-of-hospital cardiac arrest: a prospective multicenter observational study in Korea (the KORHN-PRO registry). Crit Care. 2023 Aug 9;27(1):313. doi: 10.1186/s13054-023-04603-6.

    PMID: 37559163DERIVED

  • 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.

    PMID: 31521016DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Kyu Nam Park, MD. PhD

    Seoul St. Mary's Hospital, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyu Nam Park, MD, PhD

CONTACT

82-2-2258-6301emsky@catholic.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 11, 2016

Study Start

October 1, 2015

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

October 21, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)