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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coolgard | invasive cooling |
| |
| ArcticSun | non-invasive (surface) cooling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coolgard | Device | invasive cooling via femoral ICY-catheter |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who survived sudden cardiac arrest and where treated with cooling-therapies
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| Name | Affiliation | Role |
|---|---|---|
| Holger Thiele, Associate Professor | Study Chair | Principal Investigator |
| Undine Pittl, MD | Study Sub-Investigator | Study Director |
| Alexandra Schratter, MD | Study Sub-Investigator | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Leipzig, Heart Center, Cardiology | Leipzig | 04289 | Germany | |||
| University of Leipzig, Heart Center, Cardiology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19241153 | Background | Sulaj M, Saniova B, Drobna E, Schudichova J. Serum neuron specific enolase and malondialdehyde in patients after out-of-hospital cardiac arrest. Cell Mol Neurobiol. 2009 Sep;29(6-7):807-10. doi: 10.1007/s10571-009-9361-y. Epub 2009 Feb 25. | |
| 19624826 | Background | Shinozaki K, Oda S, Sadahiro T, Nakamura M, Hirayama Y, Abe R, Tateishi Y, Hattori N, Shimada T, Hirasawa H. S-100B and neuron-specific enolase as predictors of neurological outcome in patients after cardiac arrest and return of spontaneous circulation: a systematic review. Crit Care. 2009;13(4):R121. doi: 10.1186/cc7973. Epub 2009 Jul 22. |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D007035 | Hypothermia |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
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| ArcticSun | Device | non-invasive surface cooling by saline-cooled thermo-vest |
|
|
| one year |
| Leipzig |
| Germany |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |