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

Cardiogenic Shock Clinical Trial

— ECMOsorb  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05027529
• Other study ID #: ZKSJ0131
• Secondary ID: DRKS00025265
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Jena University Hospital
• Contact: Christian Schulze, Prof.
• Phone: 004936419324100
• Email: Christian.Schulze[@]med.uni-jena.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Intervention

Device:
• CytoSorb
An extracorporeal cytokine hemoadsorption system is integrated in the VA-ECMO circuit

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

Locations

Country	Name	City	State
Germany	Jena University Hospital, Department of Cardiology	Jena	Thuringia

Sponsors (1)

Lead Sponsor	Collaborator
Christian Schulze

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Interleukin 6	pg/ml	0 to 7 days after beginning of intervention
Secondary	Procalcitonin	ng/ml	0 to 7 days after beginning of intervention
Secondary	c-reactive protein	mg/l	0 to 7 days after beginning of intervention
Secondary	lactate	mmol/l	0 to 7 days after beginning of intervention
Secondary	creatinine	µmol/l	0 to 7 days after beginning of intervention
Secondary	glomerular filtration rate (GFR)	ml/min	0 to 7 days after beginning of intervention
Secondary	troponin	pg/ml	0 to 7 days after beginning of intervention
Secondary	creatinine kinase	µmol/l*s	0 to 7 days after beginning of intervention
Secondary	myoglobine	µg/l	0 to 7 days after beginning of intervention
Secondary	urinary output	ml/h	0 to 7 days after beginning of intervention
Secondary	neuron specific enolase	µg/l	0 to 7 days after beginning of intervention
Secondary	s-100	µg/l	0 to 7 days after beginning of intervention
Secondary	cystatin c	mg/l	0 to 7 days after beginning of intervention
Secondary	galectin-3	ng/ml	0 to 7 days after beginning of intervention
Secondary	Duration of: renal replacement therapy (CVVHD), mechanical ventilation, ECMO therapy, inotropic /vasopressor treatment	hours	day 30 after beginning of intervention
Secondary	30 day, ICU and in-hospital mortality	nominal scale (yes/no)	day 30 after beginning of intervention
Secondary	Length of stay in ICU and total length of hospital stay until discharge/transfer	hours	day 30 after beginning of intervention
Secondary	Necessary Implantation of an Active Assist Device or heart transplantation	nominal scale (yes/no)	day 30 after beginning of intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	cerebreal performance category (CPC)	CPC 1 (adequate function) to CPC 5 (brain dead)	0 to 30 days after beginning of intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	Modified Rankin scale	scale from 0 (no symptoms) to 6 (dead);	0 to 30 days after beginning of intervention
Secondary	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
Secondary	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
Secondary	Measurement of kidney injury and kidney function	NGAL, KIM-1, L-FABP, IGFBP7 in ng/ml	0 to 7 days after beginning of intervention
Secondary	Interleukin 18	pg/ml	0 to 7 days after beginning of intervention
Secondary	incidence of apoplexy	nominal scale (yes/no)	30 days after beginning of intervention
Secondary	mean arterial pressure	mmHg	0 to 7 days after beginning of intervention
Secondary	central venous oxygen saturation	in %	0 to 7 days after beginning of intervention
Secondary	mixed venous oxygen saturation	in %	0 to 7 days after beginning of intervention
Secondary	arterial oxygen saturation	in %	0 to 7 days after beginning of intervention
Secondary	heart failure re-hospitalisation	nominal scale (yes/no)	30 days after beginning of intervention
Secondary	Brain natriuretic peptide (BNP)	pg/ml	0 to 7 days after beginning of intervention
Secondary	n-terminal pro brain natriuretic peptide (NT-proBNP)	pg/ml	0 to 7 days after beginning of intervention