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

Sponsor

Christian Schulze (Other)

Overall Status

Recruiting

CT.gov ID

NCT05027529

Collaborator

(none)

Enrollment

Location

Arms

24.3

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cardiogenic Shock	Device: CytoSorb Other: VA-ECMO only	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective, randomized, controlled, blinded, monocenter trialprospective, randomized, controlled, blinded, monocenter trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

masking by using a "black-box"; the control group only receives a regular ECMO tube

Primary Purpose:

Treatment

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.

Actual Study Start Date :

May 21, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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