Clinical trial NCT03578328: TaIwan Network of Targeted Temperature ManagEment for CARDiac Arrest Registry (TIMECARD)
Official title: TaIwan Network of Targeted Temperature ManagEment for CARDiac Arrest Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrest
Targeted Temperature Management
Registry
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Taipei Medical University Shuang Ho Hospital
name: Mackay Memorial Hospital
name: Taipei Veterans General Hospital, Taiwan
name: Taichung Veterans General Hospital
name: Kaohsiung Veterans General Hospital.
name: Changhua Christian Hospital
name: National Cheng-Kung University Hospital
name: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Far Eastern Memorial Hospital
First posted: 2018-07-06
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: in-hospital mortality
timeFrame: within one year
measure: favorable neurological outcome when hospital discharge
timeFrame: within one year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chien-Hua Huang
role: PRINCIPAL_INVESTIGATOR
References: