TaIwan Network of Targeted Temperature ManagEment for CARDiac Arrest Registry (TIMECARD) (TIMECARD)

TaIwan Network of Targeted Temperature ManagEment for CARDiac Arrest Registry

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.

Study Overview

• Status: Unknown
• Conditions: Cardiac Arrest; Targeted Temperature Management; Registry
• Intervention / Treatment: Procedure: targeted temperature management

Detailed Description

The importance of cardiopulmonary resuscitation has been emphasized in recent years. The chance of return of spontaneous circulation improves up to 70%. However, only 20 % of cardiac arrest patients can survive to hospital discharge because of post-cardiac arrest syndrome due to global ischemia-reperfusion injuries in cardiac arrest and resuscitation. Although there are some studies trying to predict the survival outcomes in cardiac arrest, the prediction variables are limited to the pre-arrest variables such as age, pre-morbidities. The impact of these variables on long term outcomes is neither clear nor well-defined. It is found that the chances of survival to discharge are significant different among different hospitals and districts. It implies that the intensive managements and treatment policies could influence the outcomes in cardiac arrest patients. However, the critical procedures or managements have not been systemically studied and remain undefined. Targeted temperature management based on hypothermia treatment changes the post-cardiac arrest care and improves the outcome in cardiac arrest patients. Under hypothermia treatment, the critical time points of evaluating prognosis are changed because of 24 hours maintaining cooling period and 12-18 hours rewarming period. The full neurological recovery cannot be evaluated at 24 hours after return of spontaneous circulation as the suggestion in old days without hypothermia treatment. The optimal time points for evaluating and predicting long term outcomes need to be re-defined. The accuracy of different modalities for outcome prediction also needed to be re-evaluated in the hypothermia treatment era. Early and precise prediction of good recovery and favorable outcomes are very important in determining the further intensive treatment strategies by physicians and family for cardiac arrest patients.

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.

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10002
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chien-Hua Huang, MD, PhD; Email: chhuang730@gmail.com

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

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• nil

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac arrest with targeted temperature management	Procedure: targeted temperature management; Temperature control to targeted temperature (32-36C) after return of spontaneous circulation after cardiac arrest and resuscitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
in-hospital mortality		within one year
favorable neurological outcome when hospital discharge	Cerebral Performance Category less than 3	within one year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Mackay Memorial Hospital; Kaohsiung Medical University Chung-Ho Memorial Hospital; Taipei Veterans General Hospital, Taiwan; National Cheng-Kung University Hospital; Far Eastern Memorial Hospital; Taipei Medical University Shuang Ho Hospital; Changhua Christian Hospital; Taichung Veterans General Hospital; Kaohsiung Veterans General Hospital.
• Investigators: Principal Investigator: Chien-Hua Huang, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): August 1, 2021

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: June 24, 2018
• First Posted (ACTUAL): July 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 21, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 201708013RIND

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No