ECMOsorb Trial - Impact of a VA-ECMO in Combination With CytoSorb in Critically Ill Patients With Cardiogenic Shock

Study Overview
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Brief Summary
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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
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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.

Official Title
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ECMOsorb Trial - Impact of a VA-ECMO in Combination With CytoSorb in Critically Ill Patients With Cardiogenic Shock- A Prospective, Randomized, Blinded, Monocenter Trial.

Conditions
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Cardiogenic Shock

Intervention / Treatment
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* Device: CytoSorb
* Other: VA-ECMO only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized, controlled, blinded, monocenter trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VA-ECMO and CytoSorb<br>standard ICU care WITH CytoSorb | Device: CytoSorb<br>* An extracorporeal cytokine hemoadsorption system is integrated in the VA-ECMO circuit<br>* Other names: Standard ICU care (with VA-ECMO) AND CytoSorb Adsorber;|
| Placebo Comparator: VA-ECMO only<br>standard ICU care WITHOUT CytoSorb | Other: VA-ECMO only<br>* only VA-ECMO; NO extracorporeal cytokine hemoadsorption system is added<br>* Other names: Standard ICU care (with VA-ECMO);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inotropic score after 72h (difference between the two study groups) | Inotropic Score: dopamine dose [μg/kg/min] + dobutamine dose [μg/kg/min] + 100x epinephrine dose [μg/kg/min] + 100x norepinephrine [μg/kg/min] | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin 6 | pg/ml | 0 to 7 days after beginning of intervention | 
| Procalcitonin | ng/ml | 0 to 7 days after beginning of intervention | 
| c-reactive protein | mg/l | 0 to 7 days after beginning of intervention | 
| lactate | mmol/l | 0 to 7 days after beginning of intervention | 
| creatinine | µmol/l | 0 to 7 days after beginning of intervention | 
| glomerular filtration rate (GFR) | ml/min | 0 to 7 days after beginning of intervention | 
| troponin | pg/ml | 0 to 7 days after beginning of intervention | 
| creatinine kinase | µmol/l*s | 0 to 7 days after beginning of intervention | 
| myoglobine | µg/l | 0 to 7 days after beginning of intervention | 
| urinary output | ml/h | 0 to 7 days after beginning of intervention | 
| neuron specific enolase | µg/l | 0 to 7 days after beginning of intervention | 
| s-100 | µg/l | 0 to 7 days after beginning of intervention | 
| cystatin c | mg/l | 0 to 7 days after beginning of intervention | 
| galectin-3 | ng/ml | 0 to 7 days after beginning of intervention | 
| Duration of: renal replacement therapy (CVVHD), mechanical ventilation, ECMO therapy, inotropic /vasopressor treatment | hours | day 30 after beginning of intervention | 
| 30 day, ICU and in-hospital mortality | nominal scale (yes/no) | day 30 after beginning of intervention | 
| Length of stay in ICU and total length of hospital stay until discharge/transfer | hours | day 30 after beginning of intervention | 
| Necessary Implantation of an Active Assist Device or heart transplantation | nominal scale (yes/no) | day 30 after beginning of intervention | 
| SAPS II | Simplified Acute Physiology Score II (Minimum value: 0 / maximum value: 163; higher values means worse outcome) | 0 to 7 days after beginning of intervention | 
| APACHE II score | Acute Pysiology and Chronic Health Evaluation II (Minimum value: 0 / maximum value: 71; higher values means worse outcome) | 0 to 7 days after beginning of intervention | 
| SOFA score | Sequential Organ Failure Assessment Score (Minimum value: 0 / maximum value: 24; higher value means worse outcome) | 0 to 7 days after beginning of intervention | 
| cerebreal performance category (CPC) | CPC 1 (adequate function) to CPC 5 (brain dead) | 0 to 30 days after beginning of intervention | 
| Glasgow coma scale (GCS) | Assessment scheme for disorders of consciousness and brain function (eyes, verbal, motor); scale from 3 (severe impairment) to 15 points (no abnormalities) | 0 to 30 days after beginning of intervention | 
| EuroQuol 5D-3L Descriptive System | mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. | 7 to 30 days after beginning of intervention | 
| EQ VAS | 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'. | 7 to 30 days after beginning of intervention | 
| Modified Rankin scale | scale from 0 (no symptoms) to 6 (dead); | 0 to 30 days after beginning of intervention | 
| Measurement of right ventricular parameters | 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) | 0 to 7 days after beginning of intervention | 
| Measurement of left ventricular parameters | 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) | 0 to 7 days after beginning of intervention | 
| Measurement of kidney injury and kidney function | NGAL, KIM-1, L-FABP, IGFBP7 in ng/ml | 0 to 7 days after beginning of intervention | 
| Interleukin 18 | pg/ml | 0 to 7 days after beginning of intervention | 
| incidence of apoplexy | nominal scale (yes/no) | 30 days after beginning of intervention | 
| mean arterial pressure | mmHg | 0 to 7 days after beginning of intervention | 
| central venous oxygen saturation | in % | 0 to 7 days after beginning of intervention | 
| mixed venous oxygen saturation | in % | 0 to 7 days after beginning of intervention | 
| arterial oxygen saturation | in % | 0 to 7 days after beginning of intervention | 
| heart failure re-hospitalisation | nominal scale (yes/no) | 30 days after beginning of intervention | 
| Brain natriuretic peptide (BNP) | pg/ml | 0 to 7 days after beginning of intervention | 
| n-terminal pro brain natriuretic peptide (NT-proBNP) | pg/ml | 0 to 7 days after beginning of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiogenic shock, VA-ECMO, venous arterial Extracorporeal Membrane Oxygenation, inotropic score, extracorporeal cytokine hemadsorption system, cytokine adsorber, intensive care, multi organ failure