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

Christian Schulze1 site in 1 country42 target enrollmentMay 21, 2021

ConditionsCardiogenic Shock

InterventionsVA-ECMO only CytoSorb

Overview

Phase: Not Applicable
Intervention: VA-ECMO only
Conditions: Cardiogenic Shock
Sponsor: Christian Schulze
Enrollment: 42
Locations: 1
Primary Endpoint: Change in inotropic score after 72h (difference between the two study groups)
Status: Completed
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 21, 2021

End Date

December 31, 2025

Last Updated

2 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Christian Schulze

Responsible Party

Sponsor Investigator

Principal Investigator

Christian Schulze

Prof. Dr. med.

Jena University Hospital

Eligibility Criteria

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).

Arms & Interventions

VA-ECMO only

standard ICU care WITHOUT CytoSorb

Intervention: VA-ECMO only

VA-ECMO and CytoSorb

standard ICU care WITH CytoSorb

Intervention: CytoSorb

Outcomes

Primary Outcomes

Change in inotropic score after 72h (difference between the two study groups)

Time Frame: 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 Outcomes

Interleukin 18(0 to 7 days after beginning of intervention)
incidence of apoplexy(30 days after beginning of intervention)
creatinine kinase(0 to 7 days after beginning of intervention)
s-100(0 to 7 days after beginning of intervention)
Measurement of right ventricular parameters(0 to 7 days after beginning of intervention)
c-reactive protein(0 to 7 days after beginning of intervention)
creatinine(0 to 7 days after beginning of intervention)
EuroQuol 5D-3L Descriptive System(7 to 30 days after beginning of intervention)
30 day, ICU and in-hospital mortality(day 30 after beginning of intervention)
Length of stay in ICU and total length of hospital stay until discharge/transfer(day 30 after beginning of intervention)
Necessary Implantation of an Active Assist Device or heart transplantation(day 30 after beginning of intervention)
SAPS II(0 to 7 days after beginning of intervention)
APACHE II score(0 to 7 days after beginning of intervention)
Modified Rankin scale(0 to 30 days after beginning of intervention)
Measurement of kidney injury and kidney function(0 to 7 days after beginning of intervention)
glomerular filtration rate (GFR)(0 to 7 days after beginning of intervention)
urinary output(0 to 7 days after beginning of intervention)
cystatin c(0 to 7 days after beginning of intervention)
SOFA score(0 to 7 days after beginning of intervention)
cerebreal performance category (CPC)(0 to 30 days after beginning of intervention)
Glasgow coma scale (GCS)(0 to 30 days after beginning of intervention)
EQ VAS(7 to 30 days after beginning of intervention)
mean arterial pressure(0 to 7 days after beginning of intervention)
mixed venous oxygen saturation(0 to 7 days after beginning of intervention)
Interleukin 6(0 to 7 days after beginning of intervention)
Procalcitonin(0 to 7 days after beginning of intervention)
lactate(0 to 7 days after beginning of intervention)
troponin(0 to 7 days after beginning of intervention)
myoglobine(0 to 7 days after beginning of intervention)
neuron specific enolase(0 to 7 days after beginning of intervention)
galectin-3(0 to 7 days after beginning of intervention)
Duration of: renal replacement therapy (CVVHD), mechanical ventilation, ECMO therapy, inotropic /vasopressor treatment(day 30 after beginning of intervention)
heart failure re-hospitalisation(30 days after beginning of intervention)
Measurement of left ventricular parameters(0 to 7 days after beginning of intervention)
central venous oxygen saturation(0 to 7 days after beginning of intervention)
arterial oxygen saturation(0 to 7 days after beginning of intervention)
n-terminal pro brain natriuretic peptide (NT-proBNP)(0 to 7 days after beginning of intervention)
Brain natriuretic peptide (BNP)(0 to 7 days after beginning of intervention)