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

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

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

Study Overview

• Status: Recruiting
• Conditions: Cardiogenic Shock
• Intervention / Treatment: Device: CytoSorb; Other: VA-ECMO only

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 Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Schulze, Prof.; Phone Number: 004936419324100; Email: Christian.Schulze@med.uni-jena.de
• Study Contact Backup: Name: Franz Haertel, Dr.; Phone Number: 004936419324554; Email: Franz.Haertel@med.uni-jena.de

Study Locations

• Germany
  • Thuringia
    • Jena, Thuringia, Germany, 07747
      • Recruiting
      • Jena University Hospital, Department of Cardiology
      • Contact: Christian Schulze, Prof.; Phone Number: +4936419324100; Email: Christian.Schulze@med.uni-jena.de
      • Contact: Franz Haertel, Dr.; Phone Number: +4936419324554; Email: Franz.Haertel@med.uni-jena.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Christian Schulze
• Investigators: Study Director: Christian Schulze, Prof., Jena University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: cardiogenic shock; intensive care; VA-ECMO; venous arterial Extracorporeal Membrane Oxygenation; inotropic score; extracorporeal cytokine hemadsorption system; cytokine adsorber; multi organ failure
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Shock; Shock, Cardiogenic
• Other Study ID Numbers: ZKSJ0131; DRKS00025265 (Registry Identifier: Deutsches Regsiter für Klinische Studien (DRKS))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No