Cardiogenic Shock
Conditions
Brief summary
This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.
Detailed description
Cardiogenic shock is a serious complication of a myocardial infarction. Despite optimal treatment the mortality in patients with cardiogenic shock still exceeds 50% and surviving patients mostly suffer from severe heart failure due to an impaired cardiac function. This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction. The main study hypothesis is to explore if additional treatment with ECLS preserves cardiac function (left ventricular ejection fraction) in patients with cardiogenic shock complicating acute myocardial infarction.
Interventions
DEVICEExtra-Corporal Life Support (ECLS)
Extra-Corporal Life Support (ECLS) (from Sorin)
Sponsors
LMU Klinikum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Best medical therapy versus best medical therapy + ECLS in the treatment of cardiogenic shock complicating acute myocardial infarction
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with * intended revascularization (PCI or CABG) * Systolic blood pressure \< 90 mmHg \> 30 min or inotropes required to maintain pressure \> 90 mmHg during systole * Signs of left heart insufficiency and pulmonary congestion * Signs of impaired organ perfusion with at least one of the following: * Altered mental status * Cold, clammy skin * Urine output \<30 ml/h * Serum lactate \>2mmol/l * Informed consent
Exclusion criteria
* Resuscitation \> 60 minutes, ischemia \> 10 minutes * No intrinsic heart action * Cerebral deficit with fixed dilated pupils * Mechanical infarction complication * Onset of shock \> 12 h * Severe peripheral artery disease * Aortic regurgitation \> II.° * Age \> 80 years * shock of other cause * Other severe concomitant disease * participation in another trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular ejection fraction (LVEF) on day 30 | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Lactate levels | up to 48 hours |
| potentia hydrogenic levels | 48 hours |
| Length of mechanical ventilation | 30 days |
| 30-day mortality | 30 days |
| Length of ICU stay | 30 days |
| Neurological Outcome (modified Rankin Scale) | up to 12 months |
| MACE (defined as cardiac death, non-fatal myocardial re-infarction, rehospitalisation for cardiac reasons and the need of CABG or PCI) | up to 12 months |
| Long-term mortality at 12 months | up to 12 months |
Countries
Germany
Outcome results
None listed