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

Cardiac Arrest Clinical Trial

— TIMECARD  

Official title:

TaIwan Network of Targeted Temperature ManagEment for CARDiac Arrest Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03578328
• Other study ID #: 201708013RIND
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: August 2021

Study information

• Verified date: July 2019
• Source: National Taiwan University Hospital
• Contact: Chien-Hua Huang, MD, PhD
• Phone: 886-2-23562831
• Email: chhuang730[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Registry
• Targeted Temperature Management

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (10)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Changhua Christian Hospital, Far Eastern Memorial Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Veterans General Hospital., Mackay Memorial Hospital, National Cheng-Kung University Hospital, Taichung Veterans General Hospital, Taipei Medical University Shuang Ho Hospital, Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-hospital mortality		within one year
Primary	favorable neurological outcome when hospital discharge	Cerebral Performance Category less than 3	within one year