Patients in cardiogenic shock complicating acute myocardial infarction (AMI) are referred to a tertiary care center for percutaneous coronary intervention (PCI) of the infarct related artery in this multicenter, ran-domized clinical trial. After checking in- and exclusion criteria computerized randomization is performed to either PCI plus intraaortic balloon pump (IABP) insertion and medical treatment or PCI plus medical treatment only. Intensive care treatment is performed according to standard care including hemodynamic monitoring using a pulmonary artery catheter for optimal volume status adaptation and inotropic drug administration. The IABP will be weaned after hemodynamic stabilization. Primary outcome measure will be 30-day mortality. The secondary outcome measures such as hemody-namic, laboratory and clinical parameters will serve as surrogate for prognosis of the patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used
Zentralklinik Bad Berka GmbH
Bad Berka, Germany
Herzzentrum Bad Krozingen
Bad Krozingen, Germany
Segeberger Kliniken Gmbh
Bad Segeberg, Germany
Charité Berlin, Campus Benjamin Franklin
Berlin, Germany
Heart Center Bernau - Brandenburg
Bernau, Germany
Herzzentrum Cottbus
Cottbus, Germany
Klinikum Lippe-Detmold
Detmold, Germany
Krankenhaus Fulda
Fulda, Germany
University Greifswald
Greifswald, Germany
Martin-Luther-Universität Halle-Wittenberg
Halle, Germany
...and 10 more locations
30-day mortality
Time frame: 30 day
Inflammatory markers (CRP and white blood cell count)
Time frame: 4 days
Hemodynamic Parameters (Blood pressure, Heart rate)
Time frame: 3 days
Time till hemodynamic stabilization
Time frame: 30 days
Catecholamine dose and duration of catecholamines
Time frame: 30 days
Mean and area under the curve of serum lactate
Time frame: 48 hours
Creatinine clearance until stabilization
Time frame: 4 days
requirement for hemofiltration or dialysis
Time frame: 4 days
length of ICU stay
Time frame: 30 days
length of mechanical ventilation
Time frame: 30 days
SAPS-II Score
Time frame: 4 days
requirement for active assist device implantation or heart transplantation at 30 days and approximately 60 months
Time frame: 60 months
long-term mortality at 6, 12 and approximately 60 months
Time frame: 60 months
quality of life at 30 days and approximately 60 months
Time frame: 60 months
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