Extracorporeal Life Support in Cardiogenic Shock
- Conditions
- Acute Myocardial InfarctionCardiogenic Shock
- Registration Number
- NCT03637205
- Lead Sponsor
- Helios Health Institute GmbH
- Brief Summary
The aim of the study is to examine whether treatment with extracorporeal life support (ECLS) in addition to revascularization with percutaneous coronary intervention (PCI) or alternatively coronary artery bypass grafting (CABG) and optimal medical treatment is beneficial in comparison to no ECLS in patients with severe infarctrelated cardiogenic shock with respect to 30-day mortality
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
- Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory:
- Planned revascularization (PCI or alternatively CABG)
- Systolic blood pressure <90 mmHg >30 min or catecholamines required to maintain pressure >90 mmHg during Systole
- Signs of impaired organ perfusion with at least one of the following criteria a) Altered mental Status, b) Cold, clammy skin and extremities, c) Oliguria with urine output <30 ml/h
- Arterial lactate >3 mmol/l
- Informed consent
- Resuscitation >45 minutes
- Mechanical cause of cardiogenic shock
- Onset of shock >12 h
- Severe peripheral artery disease with impossibility to insert ECLS cannulae
- Age <18 years or age >75 years
- Shock of other cause (bradycardia, sepsis, hypovolemia, etc.)
- Other severe concomitant disease with limited life expectancy <6 months
- Pregnancy
- Participation in another trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 30-day mortality 30 days 30-day all-cause death after randomization according to the intention-to-treat principle
- Secondary Outcome Measures
Name Time Method Time to hemodynamic stabilization 0 to 10 days Length of ICU stay 0 to 11 days Serial creatinine-level and creatinine-clearance 0 to 10 days from time of randomization until stabilization Creatinine-clearance (Cockcroft-Gault-Formula)
Serial SAPS-II score 0 to 11 days Status of Quality of life measured by EQ VAS 12 months The EuroQol Group visual analogue scale (EQ VAS) records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the maximum 100 is labelled 'The best health you can imagine' and the minimum 0 is labelled 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Length of hospital stay 0 to 14 days Acute renal failure requiring renal replacement therapy 0 to 14 days Hospitalization for heart failure 6 and 12 months Time to death within 6 and 12 months follow-up 6 and 12 months Length of mechanical ventilation 0 to 10 days Cerebral performance category (CPC) 30 days, 6 and 12 months Recurrent infarction 30 days, 6 and 12 months Duration of catecholamine therapy 0 to 10 days Cardiovascular mortality 6 and 12 months Repeat revascularization (PCI or CABG) 30 days, 6 and 12 months Status of Quality of life measured by EQ-5D-5L descriptive system 12 months The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems expressed by 1-digit-numbers ranging from 1 (extreme problems) to 5 (no problems). The toal score ranges from 0-15 where 15 is the worst score.
Mean and area under the curve of arterial lactate 0 to 14 days
Trial Locations
- Locations (46)
Universitätsklinikum Aachen
🇩🇪Aachen, Germany
Zentralklinik Bad Berka GmbH
🇩🇪Bad Berka, Germany
SLK-Kliniken Heilbronn GmbH Klinikum Am Plattenwald
🇩🇪Bad Friedrichshall, Germany
Kerckhoff-Klinik Forschungsgesellschaft mbH
🇩🇪Bad Nauheim, Germany
Charité Universitätsmedizin Berlin, CBF Medizinische Klinik für Kardiologie
🇩🇪Berlin, Germany
BG Klinikum Unfallkrankenhaus Berlin gGmbH
🇩🇪Berlin, Germany
St-Johannes-Hospital Klinik für Innere Medizin I
🇩🇪Dortmund, Germany
Technische Universität Dresden
🇩🇪Dresden, Germany
Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie und Angiologie
🇩🇪Düsseldorf, Germany
Helios Klinikum Erfurt 3. Medizinische Klinik
🇩🇪Erfurt, Germany
Scroll for more (36 remaining)Universitätsklinikum Aachen🇩🇪Aachen, Germany