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Mild therapeutic hypothermia in the temperature range of 32º - 34ºC. improves survival in patients recovered from a ventricular fibrillation cardiac arrest. The same therapy is suggested with less evidence for asystole as first rhythm after cardiac arrest. The purpose of this study is to determine whether different temperature targets (32º vs 34º) may have different efficacy in the treatment of post-cardiac arrest patients. If successful, this pilot study will eventually form the basis for a larger, multicentric randomized clinical trial.
Patients admitted consecutively were potentially eligible for the study if they had a witnessed out-off hospital cardiac arrest (OHCA) apparently related to heart disease and an interval of <60 minutes from collapse to return of spontaneous circulation (ROSC). Additional inclusion criteria were:
Exclusion criteria were:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 32º Celsius | Active Comparator | Endovascular Cooling was set at a target temperature of 32°C |
|
| 34º Celsius | Active Comparator | Endovascular Cooling was set at a target temperature of 32°C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Cooling | Procedure | Infusion of <8°C cold saline followed by the implantation of the Icy 9.3F 38-cm catheter (ZOLL Medical Corporation, Chelmsford, MA) placed in the inferior vena cava through a femoral vein connected to the Thermogard XP Temperature Management System (ZOLL Medical Corporation). Cooling was set at a maximum rate with a target temperature of 32°C or 34°C according to randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival free from severe dependence (Barthel index <60) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival at 6 months | 6 months | |
| Barthel Index at 6 months | 6 months | |
| Life threatening arrhythmias in different hypothermia temperatures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esteban Lopez-de-Sa, MD, FESC | Intensive Cardiac Care Unit. Department of Cardiology. Hospital Universitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive Cardiac Care Unit. Hospital Universitario la Paz | Madrid | Madrid | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23136160 | Result | Lopez-de-Sa E, Rey JR, Armada E, Salinas P, Viana-Tejedor A, Espinosa-Garcia S, Martinez-Moreno M, Corral E, Lopez-Sendon J. Hypothermia in comatose survivors from out-of-hospital cardiac arrest: pilot trial comparing 2 levels of target temperature. Circulation. 2012 Dec 11;126(24):2826-33. doi: 10.1161/CIRCULATIONAHA.112.136408. Epub 2012 Nov 6. |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D007035 | Hypothermia |
| D001145 | Arrhythmias, Cardiac |
| D058687 | Out-of-Hospital Cardiac Arrest |
| D000080942 | Post-Cardiac Arrest Syndrome |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
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|
New life-threatening arrhythmias during hypothermia: ventricular fibrillation, sustained (>30 sec.) monomorphic or polymorphic ventricular tachycardia, extreme bradycardia (heart rate <35 bpm. and/or pauses >3 sec.) |
| 48 hours (during hypothermia) |
| Impact on ventricular function of different hypothermia temperatures | Echocardiographic evaluation of possible impact of different hypothermia temperatures on ventricular diastolic and systolic function | 48 hours During hypothermia |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D015427 | Reperfusion Injury |
| D014652 | Vascular Diseases |
| D011183 | Postoperative Complications |