Prospective, randomized, single-center, controlled, open-label Pilot-study to investigate whether induction of mild hypothermia in addition to primary percutaneous coronary intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic shock improves cardiac power index after 24 h.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Induction of mild hypothermia with invasive cooling for 24 hr in addition to primary percutaneous coronary intervention and optimal medical therapy.
Department of Internal Medicine/Cardiology, University of Leipzig - Heart Center
Leipzig, Saxony, Germany
Cardiac Power Index after 24 hr.
Cardiac Power Index after 24 hours as surrogate endpoint.
Time frame: 24 hours
30-days mortality
Time frame: 30 days
Change of hemodynamics over the first 48 hr.
Time frame: During first 48 hr
Catecholamine dose and duration of catecholamine support
Time frame: 30 days
Length of ICU-stay
Time frame: 30 days
Length of mechanical ventilation
Time frame: 30 days
SAPS-II-Score
Simplified Acute Physiology Score for the first 4 days
Time frame: 96 hours
Severe and moderate bleeding complications (GUSTO-definition)
Time frame: 30 days
Sepsis
Time frame: 30 days
Pneumonia
Time frame: 30 days
Stroke
Time frame: 30 days
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