COOL-Trial: Outcome With Invasive and Non-invasive Cooling After Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the efficacy and side effects of therapeutic hypothermia in an unselected group of patients after SCA.

Detailed Description
-----------------
Consecutive patients with restoration of spontaneous circulation (ROSC) after resuscitation due to out-of-hospital SCA, admitted to our intensive care unit, underwent MIH. Hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive Coolgard or non-invasive ArcticSun). The core body temperature was operated at 32 to 34 °C over a period of 24 hours followed by active rewarming. Neurological status was evaluated at hospital discharge and 6 months after discharge using the Pittsburgh Cerebral Performance Category (CPC). Blood samples of neuron-specific enolase (NSE) were collected during 72 hours.

Official Title
-----------------
Clinical and Neurological Outcome With Two Different Cooling Methods (Invasive and Non-invasive) After Sudden Cardiac Arrest

Conditions
-----------------
Cardiac Arrest, Hypothermia

Intervention / Treatment
-----------------
* Device: Coolgard
* Device: ArcticSun
* Other: Conventional treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ROSC after SCA due to VF/VT or PEA/Asystolia GCS 3 Exclusion Criteria: Non-cardiac SCA Pregnancy Unstable Circulation instead of High-dose Inotropics Life-expectancy reducing concomitant illness
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CG<br>Coolgard: invasive Cooling | Device: Coolgard<br>* invasive Cooling via femoral ICY-catheter<br>|
| Active Comparator: AS<br>ArcticSun: Surface-Cooling | Device: ArcticSun<br>* Noninvasive surface-cooling by saline-cooled thermo-vest<br>|
| Sham Comparator: UnCOOL<br>No Cooling-Therapy due to non-operational cooling-devices | Other: Conventional treatment<br>* Intensive care-treatment without cooling<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach the target temperature |  | Twenty-four hours | 
| NSE as a parameter for cerebral damage |  | Seventy-two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurologic outcome |  | Six months | 
| Survival |  | Six months | 
| Periprocedural complications |  | Seventy-two hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sudden Cardiac Arrest, Hypothermia, Outcome, neurological, Coolgard, ArcticSun