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

Not Applicable

Recruiting

• Conditions: Cardiogenic Shock
• Interventions: Other: VA-ECMO only; Device: CytoSorb

• Registration Number: NCT05027529
• Lead Sponsor: Christian Schulze

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.

Study Timeline

• Study First Submitted: 2021-03-12
• Study Start: 2021-05-21
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VA-ECMO only	VA-ECMO only	standard ICU care WITHOUT CytoSorb
VA-ECMO and CytoSorb	CytoSorb	standard ICU care WITH CytoSorb

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
incidence of apoplexy	30 days after beginning of intervention	nominal scale (yes/no)
creatinine kinase	0 to 7 days after beginning of intervention	µmol/l\*s
s-100	0 to 7 days after beginning of intervention	µg/l
c-reactive protein	0 to 7 days after beginning of intervention	mg/l
creatinine	0 to 7 days after beginning of intervention	µmol/l
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.
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)
Interleukin 18	0 to 7 days after beginning of intervention	pg/ml
Length of stay in ICU and total length of hospital stay until discharge/transfer	day 30 after beginning of intervention	hours
30 day, ICU and in-hospital mortality	day 30 after beginning of intervention	nominal scale (yes/no)
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)
Modified Rankin scale	0 to 30 days after beginning of intervention	scale from 0 (no symptoms) to 6 (dead);
Measurement of kidney injury and kidney function	0 to 7 days after beginning of intervention	NGAL, KIM-1, L-FABP, IGFBP7 in ng/ml
glomerular filtration rate (GFR)	0 to 7 days after beginning of intervention	ml/min
urinary output	0 to 7 days after beginning of intervention	ml/h
cystatin c	0 to 7 days after beginning of intervention	mg/l
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)
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'.
mean arterial pressure	0 to 7 days after beginning of intervention	mmHg
mixed venous oxygen saturation	0 to 7 days after beginning of intervention	in %
Interleukin 6	0 to 7 days after beginning of intervention	pg/ml
Procalcitonin	0 to 7 days after beginning of intervention	ng/ml
lactate	0 to 7 days after beginning of intervention	mmol/l
troponin	0 to 7 days after beginning of intervention	pg/ml
myoglobine	0 to 7 days after beginning of intervention	µg/l
neuron specific enolase	0 to 7 days after beginning of intervention	µg/l
galectin-3	0 to 7 days after beginning of intervention	ng/ml
Duration of: renal replacement therapy (CVVHD), mechanical ventilation, ECMO therapy, inotropic /vasopressor treatment	day 30 after beginning of intervention	hours
heart failure re-hospitalisation	30 days after beginning of intervention	nominal scale (yes/no)
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)
central venous oxygen saturation	0 to 7 days after beginning of intervention	in %
arterial oxygen saturation	0 to 7 days after beginning of intervention	in %
n-terminal pro brain natriuretic peptide (NT-proBNP)	0 to 7 days after beginning of intervention	pg/ml
Brain natriuretic peptide (BNP)	0 to 7 days after beginning of intervention	pg/ml

Trial Locations

Locations (1)

Jena University Hospital, Department of Cardiology; 🇩🇪 Jena, Thuringia, Germany