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: 1. Age \>18 years. 2. Initial registered rhythm of a shockable rhythm (ventricular fibrillation or pulseless ventricular tachycardia) or asystole. Exclusion criteria were: 1. Known pregnancy 2. Glasgow Coma Scale score after ROSC \>8. 3. Cardiogenic shock (a systolic blood pressure of \<80 mm Hg despite inotrope infusion \>30 minutes). 4. Other nonshockable rhythms (pulseless electric activity). 5. Terminal illness present before the OHCA. 6. Possible causes of coma other than cardiac arrest (drug overdose, head trauma, or cerebrovascular accident).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
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.
Intensive Cardiac Care Unit. Hospital Universitario la Paz
Madrid, Madrid, Spain
Survival free from severe dependence (Barthel index <60)
Time frame: 6 months
Survival at 6 months
Time frame: 6 months
Barthel Index at 6 months
Time frame: 6 months
Life threatening arrhythmias in different hypothermia temperatures
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.)
Time frame: 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
Time frame: 48 hours During hypothermia
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