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

Christian Schulze42 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cardiogenic Shock

Interventions

CytoSorbDEVICE

An extracorporeal cytokine hemoadsorption system is integrated in the VA-ECMO circuit

VA-ECMO onlyOTHER

only VA-ECMO; NO extracorporeal cytokine hemoadsorption system is added

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Jena University Hospital, Department of Cardiology

Jena, Thuringia, Germany

Outcomes

Primary Outcomes

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 \[μg/kg/min\]

Time frame: 72 hours

Secondary Outcomes

Interleukin 6

pg/ml

Time frame: 0 to 7 days after beginning of intervention

Procalcitonin

ng/ml

Time frame: 0 to 7 days after beginning of intervention

c-reactive protein

mg/l

Time frame: 0 to 7 days after beginning of intervention

lactate

mmol/l

Time frame: 0 to 7 days after beginning of intervention

creatinine

µmol/l

Time frame: 0 to 7 days after beginning of intervention

glomerular filtration rate (GFR)

ml/min

Time frame: 0 to 7 days after beginning of intervention

troponin

pg/ml

Time frame: 0 to 7 days after beginning of intervention

creatinine kinase

µmol/l\*s

Time frame: 0 to 7 days after beginning of intervention

Data from ClinicalTrials.gov

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myoglobine

µg/l

Time frame: 0 to 7 days after beginning of intervention

urinary output

ml/h

Time frame: 0 to 7 days after beginning of intervention

neuron specific enolase

µg/l

Time frame: 0 to 7 days after beginning of intervention

s-100

µg/l

Time frame: 0 to 7 days after beginning of intervention

cystatin c

mg/l

Time frame: 0 to 7 days after beginning of intervention

galectin-3

ng/ml

Time frame: 0 to 7 days after beginning of intervention

Duration of: renal replacement therapy (CVVHD), mechanical ventilation, ECMO therapy, inotropic /vasopressor treatment

hours

Time frame: day 30 after beginning of intervention

30 day, ICU and in-hospital mortality

nominal scale (yes/no)

Time frame: day 30 after beginning of intervention

Length of stay in ICU and total length of hospital stay until discharge/transfer

hours

Time frame: day 30 after beginning of intervention

Necessary Implantation of an Active Assist Device or heart transplantation

nominal scale (yes/no)

Time frame: day 30 after beginning of intervention

SAPS II

Simplified Acute Physiology Score II (Minimum value: 0 / maximum value: 163; higher values means worse outcome)

Time frame: 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)

Time frame: 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)

Time frame: 0 to 7 days after beginning of intervention

cerebreal performance category (CPC)

CPC 1 (adequate function) to CPC 5 (brain dead)

Time frame: 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)

Time frame: 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.

Time frame: 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'.

Time frame: 7 to 30 days after beginning of intervention

Modified Rankin scale

scale from 0 (no symptoms) to 6 (dead);

Time frame: 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)

Time frame: 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)

Time frame: 0 to 7 days after beginning of intervention

Measurement of kidney injury and kidney function

NGAL, KIM-1, L-FABP, IGFBP7 in ng/ml

Time frame: 0 to 7 days after beginning of intervention

Interleukin 18

pg/ml

Time frame: 0 to 7 days after beginning of intervention

incidence of apoplexy

nominal scale (yes/no)

Time frame: 30 days after beginning of intervention

mean arterial pressure

mmHg

Time frame: 0 to 7 days after beginning of intervention

central venous oxygen saturation

in %

Time frame: 0 to 7 days after beginning of intervention

mixed venous oxygen saturation

in %

Time frame: 0 to 7 days after beginning of intervention

arterial oxygen saturation

in %

Time frame: 0 to 7 days after beginning of intervention

heart failure re-hospitalisation

nominal scale (yes/no)

Time frame: 30 days after beginning of intervention

Brain natriuretic peptide (BNP)

pg/ml

Time frame: 0 to 7 days after beginning of intervention

n-terminal pro brain natriuretic peptide (NT-proBNP)

pg/ml

Time frame: 0 to 7 days after beginning of intervention