Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction
Not Applicable
Completed
- Conditions
- Cardiogenic ShockAcute; Myocardial Infarction, Complications
- Registration Number
- NCT01890317
- Lead Sponsor
- University of Leipzig
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Acute myocardial infarction complicated by cardiongenic shock
- Patients on mechanical ventilation at time of randomization
Exclusion Criteria
- Out of hospital resuscitation with indication for mild hypothermia
- mechanical complications after acute myocardial infarction
- duration of cardiogenic shock > 12 hours
- age > 90 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Cardiac Power Index after 24 hr. 24 hours Cardiac Power Index after 24 hours as surrogate endpoint.
- Secondary Outcome Measures
Name Time Method 30-days mortality 30 days Catecholamine dose and duration of catecholamine support 30 days Length of ICU-stay 30 days SAPS-II-Score 96 hours Simplified Acute Physiology Score for the first 4 days
Sepsis 30 days Stroke 30 days Change of hemodynamics over the first 48 hr. During first 48 hr Severe and moderate bleeding complications (GUSTO-definition) 30 days Pneumonia 30 days Length of mechanical ventilation 30 days
Trial Locations
- Locations (1)
Department of Internal Medicine/Cardiology, University of Leipzig - Heart Center
🇩🇪Leipzig, Sachsen, Germany
Department of Internal Medicine/Cardiology, University of Leipzig - Heart Center🇩🇪Leipzig, Sachsen, Germany