Cardiogenic Shock
Conditions
Keywords
cardiogenic shock, VA-ECMO, venous arterial Extracorporeal Membrane Oxygenation, inotropic score, extracorporeal cytokine hemadsorption system, cytokine adsorber, intensive care, multi organ failure
Brief summary
In the ECMOsorb study the impact of a veno-arterial -ECMO in combination with an extracorporeal cytokine hemadsorption system in critically ill patients with cardiogenic shock is to be examined
Detailed description
The prospective, interventional, randomised controlled and blinded ECMOsorb study investigates in critically ill patinets with cardiogenic shock and with veno-arterial ECMO (VA-ECMO) treatment the impact of an extracorporeal cytokin hemadsorption system on hemodynamics, defined by the Inotropic Score 72 hours after initiation of the adsorber (intervention) or normal ECMO tube (control) in the VA-ECMO.
Interventions
DEVICECytoSorb
An extracorporeal cytokine hemoadsorption system is integrated in the VA-ECMO circuit
OTHERVA-ECMO only
only VA-ECMO; NO extracorporeal cytokine hemoadsorption system is added
Sponsors
Christian Schulze
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
masking by using a "black-box"; the control group only receives a regular ECMO tube
Intervention model description
prospective, randomized, controlled, blinded, monocenter trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Cardiogenic shock of any cause and indication for VA-ECMO * Age between 18 and 80 * Signed informed consent
Exclusion criteria
* Current participation in another interventional trial * Pregnancy * Current immunosuppressive or immunomodulatory therapy * Contraindications to VA-ECMO implantation. * Patients with pre - existing sepsis (raised CPR, positive PCT, leukozytosis, fever, positive blood cultures). * Shock duration\> 12 h before evaluation. * Severe PVD (peripheral vessel disease) making ECMO-implantation impossible. * Aortic valve insufficiency / stenosis at least II °. * Age \> 80 years. * CNS disease with fixed, dilated pupils (not drug-induced). * Severe concomitant disease with limited life expectancy \<6 months. * CPR\> 60min. * Shock due to other reasons * HIT positive (Heparin induced thrombocytopenia) * Very low platelet counts (\< 20,000/µl) * Body weight less than 45 kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in inotropic score after 72h (difference between the two study groups) | 72 hours | Inotropic Score: dopamine dose \[μg/kg/min\] + dobutamine dose \[μg/kg/min\] + 100x epinephrine dose \[μg/kg/min\] + 100x norepinephrine \[μg/kg/min\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| glomerular filtration rate (GFR) | 0 to 7 days after beginning of intervention | ml/min |
| troponin | 0 to 7 days after beginning of intervention | pg/ml |
| creatinine kinase | 0 to 7 days after beginning of intervention | µmol/l\*s |
| myoglobine | 0 to 7 days after beginning of intervention | µg/l |
| urinary output | 0 to 7 days after beginning of intervention | ml/h |
| neuron specific enolase | 0 to 7 days after beginning of intervention | µg/l |
| s-100 | 0 to 7 days after beginning of intervention | µg/l |
| cystatin c | 0 to 7 days after beginning of intervention | mg/l |
| galectin-3 | 0 to 7 days after beginning of intervention | ng/ml |
| Interleukin 6 | 0 to 7 days after beginning of intervention | pg/ml |
| Procalcitonin | 0 to 7 days after beginning of intervention | ng/ml |
| c-reactive protein | 0 to 7 days after beginning of intervention | mg/l |
| lactate | 0 to 7 days after beginning of intervention | mmol/l |
| Duration of: renal replacement therapy (CVVHD), mechanical ventilation, ECMO therapy, inotropic /vasopressor treatment | day 30 after beginning of intervention | hours |
| 30 day, ICU and in-hospital mortality | day 30 after beginning of intervention | nominal scale (yes/no) |
| Length of stay in ICU and total length of hospital stay until discharge/transfer | day 30 after beginning of intervention | hours |
| Necessary Implantation of an Active Assist Device or heart transplantation | day 30 after beginning of intervention | nominal scale (yes/no) |
| SAPS II | 0 to 7 days after beginning of intervention | Simplified Acute Physiology Score II (Minimum value: 0 / maximum value: 163; higher values means worse outcome) |
| APACHE II score | 0 to 7 days after beginning of intervention | Acute Pysiology and Chronic Health Evaluation II (Minimum value: 0 / maximum value: 71; higher values means worse outcome) |
| SOFA score | 0 to 7 days after beginning of intervention | Sequential Organ Failure Assessment Score (Minimum value: 0 / maximum value: 24; higher value means worse outcome) |
| cerebreal performance category (CPC) | 0 to 30 days after beginning of intervention | CPC 1 (adequate function) to CPC 5 (brain dead) |
| Glasgow coma scale (GCS) | 0 to 30 days after beginning of intervention | Assessment scheme for disorders of consciousness and brain function (eyes, verbal, motor); scale from 3 (severe impairment) to 15 points (no abnormalities) |
| EuroQuol 5D-3L Descriptive System | 7 to 30 days after beginning of intervention | mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. |
| EQ VAS | 7 to 30 days after beginning of intervention | EQ visual analogue scale (EQ VAS), patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. |
| Modified Rankin scale | 0 to 30 days after beginning of intervention | scale from 0 (no symptoms) to 6 (dead); |
| Measurement of right ventricular parameters | 0 to 7 days after beginning of intervention | measurements of right ventricular function in the echo (TAPSE in mm; FAC in %; RVEDD in mm; sPAP in mmHg; RA area in cm²; TASV in cm/s; ICV in mm) |
| Measurement of left ventricular parameters | 0 to 7 days after beginning of intervention | measurements of left ventricular function in the echo (LVEDD in mm; LVESD in mm; LVEF in %; VSD (yes/no); LVEDV in ml; LVESV in ml; GLS in %; LA volume in ml) |
| Measurement of kidney injury and kidney function | 0 to 7 days after beginning of intervention | NGAL, KIM-1, L-FABP, IGFBP7 in ng/ml |
| Interleukin 18 | 0 to 7 days after beginning of intervention | pg/ml |
| incidence of apoplexy | 30 days after beginning of intervention | nominal scale (yes/no) |
| mean arterial pressure | 0 to 7 days after beginning of intervention | mmHg |
| central venous oxygen saturation | 0 to 7 days after beginning of intervention | in % |
| mixed venous oxygen saturation | 0 to 7 days after beginning of intervention | in % |
| arterial oxygen saturation | 0 to 7 days after beginning of intervention | in % |
| heart failure re-hospitalisation | 30 days after beginning of intervention | nominal scale (yes/no) |
| Brain natriuretic peptide (BNP) | 0 to 7 days after beginning of intervention | pg/ml |
| creatinine | 0 to 7 days after beginning of intervention | µmol/l |
| n-terminal pro brain natriuretic peptide (NT-proBNP) | 0 to 7 days after beginning of intervention | pg/ml |
Countries
Germany
Contacts
STUDY_DIRECTORChristian Schulze, Prof.
Jena University Hospital
Outcome results
None listed