NCT03578328

Brief Summary

The goals of the study are to establish the study cohort and database for out-of-hospital cardiac arrest patients. Indications and factors influencing the application of hypothermia treatment on cardiac arrest patients will be analyzed. The prognostic evaluation modalities under hypothermia treatment will be evaluated for their accuracy and optimal time points. These finding and results could be applied in clinical practice in the future.

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
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

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

June 1, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

June 23, 2020

Status Verified

July 1, 2019

Enrollment Period

3.2 years

First QC Date

June 12, 2018

Last Update Submit

June 21, 2020

Conditions

Cardiac ArrestTargeted Temperature ManagementRegistry

Outcome Measures

Primary Outcomes (2)

  • in-hospital mortality

    within one year

  • favorable neurological outcome when hospital discharge

    Cerebral Performance Category less than 3

    within one year

Study Arms (1)

Cardiac arrest with targeted temperature management

Procedure: targeted temperature management

Interventions

targeted temperature managementPROCEDURE

Temperature control to targeted temperature (32-36C) after return of spontaneous circulation after cardiac arrest and resuscitation

Cardiac arrest with targeted temperature management

Eligibility Criteria

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

Adult, non-traumatic, in- or out-of-hospital cardiac arrest patients after cardiopulmonary resuscitation with return of spontaneous circulation. Comatose, defined as Glasgow Coma Score (motor+eye) \< 8 or cannot obey verbal command Receiving targeted temperature management within 12 hours after return of spontaneous circulation

You may qualify if:

  • Age ≧18
  • Non-traumatic cardiac arrest
  • in- or out-of-hospital cardiac arrest requiring cardiopulmonary resuscitation
  • Comatose, defined as Glasgow Coma Score (motor+eye) \< 8 or cannot obey verbal command
  • Within 12 hours of return of spontaneous circulation

You may not qualify if:

  • nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Related Publications (1)

  • Chang HC, Tsai MS, Kuo LK, Hsu HH, Huang WC, Lai CH, Huang CH. Analysis of possible factors affecting neurologic outcomes of resuscitated cardiac arrest patients with initial non-shockable rhythm after targeted temperature management. J Formos Med Assoc. 2025 Apr 2:S0929-6646(25)00143-3. doi: 10.1016/j.jfma.2025.03.025. Online ahead of print.

    PMID: 40180874DERIVED

MeSH Terms

Conditions

Heart Arrest

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CryotherapyTherapeutics

Study Officials

  • Chien-Hua Huang

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Hua Huang, MD, PhD

CONTACT

886-2-23562831chhuang730@gmail.com

Chien-Hua Huang

CONTACT

886-2-23562831chhuang730@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2018

First Posted

July 6, 2018

Study Start

June 1, 2018

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

June 23, 2020

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

No sharing

Locations

TW(1)