Neuron Specific Enolase (NSE) as Outcome Parameter of Cooling Therapy After Survived Sudden Cardiac Death

Study Overview
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Brief Summary
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Sudden cardiac death remains one of the major leading causes of death. Therapeutic hypothermia is a validated standard procedure to avoid or minimize cognitive deficits after cardiac arrest. To assess the efficiency of different cooling methods and further improve these methods, the investigators collected blood samples to measure the neuron specific enolase (NSE) in patients treated with invasive cooling as compared to patients treated with non-invasive cooling.

Detailed Description
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Consecutive patients with restoration of spontaneous circulation after resuscitation due to sudden cardiac death were randomized to either non-invasive or invasive cooling for at least 24 hours. NSE was collected at designated time points and compared between patients treated with invasive cooling and those treated with non-invasive cooling. Neurological outcome was assessed between groups at hospital discharge and 6 months after discharge.

Official Title
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NSE as an Outcome Predictor of Therapeutical Hypothermia After Survived Sudden Cardiac Death

Conditions
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Cardiac Arrest, Hypothermia

Intervention / Treatment
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* Device: Coolgard
* Device: ArcticSun


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ROSC after sudden cardiac death (SCA) due to VF/VT or PEA/Asystolia GCS 3 Exclusion Criteria: Non-cardiac sudden death Pregnancy Unstable circulation with high-dose inotropics Life-expectancy reducing concomitant illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coolgard<br>invasive cooling | Device: Coolgard<br>* invasive cooling via femoral ICY-catheter<br>* Other names: CG;|
| ArcticSun<br>non-invasive (surface) cooling | Device: ArcticSun<br>* non-invasive surface cooling by saline-cooled thermo-vest<br>* Other names: AS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuron specific enolase (NSE) as a parameter for cerebral damage | Blood samples were collected at predefined time-points within 72 hours to measure neuron specific enolase. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurologic outcome | At 6 months after cardiac arrest, the cerebral performance category score is assessed to determine neurologic outcome. | 6 months | 
| time to overall survival | At one year after cardiac arrest, overall survival of the cardiac arrest patients is assessed. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sudden cardiac arrest, Hypothermia, Coolgard, arctic sun, neurological outcome, neuron specific enolase