Clinical trial NCT05027529: ECMOsorb Trial - Impact of a VA-ECMO in Combination with CytoSorb in Critically Ill Patients with Cardiogenic Shock
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiogenic Shock
Keywords: cardiogenic shock
VA-ECMO
venous arterial Extracorporeal Membrane Oxygenation
inotropic score
extracorporeal cytokine hemadsorption system
cytokine adsorber
intensive care
multi organ failure
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, controlled, blinded, monocenter trial
Primary purpose: TREATMENT

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.

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).
* 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

Primary outcomes:
measure: Change in inotropic score after 72h (difference between the two study groups)
timeFrame: 72 hours
Secondary outcomes:
measure: Interleukin 6
timeFrame: 0 to 7 days after beginning of intervention
measure: Procalcitonin
timeFrame: 0 to 7 days after beginning of intervention
measure: c-reactive protein
timeFrame: 0 to 7 days after beginning of intervention
measure: lactate
timeFrame: 0 to 7 days after beginning of intervention
measure: creatinine
timeFrame: 0 to 7 days after beginning of intervention
measure: glomerular filtration rate (GFR)
timeFrame: 0 to 7 days after beginning of intervention
measure: troponin
timeFrame: 0 to 7 days after beginning of intervention
measure: creatinine kinase
timeFrame: 0 to 7 days after beginning of intervention
measure: myoglobine
timeFrame: 0 to 7 days after beginning of intervention
measure: urinary output
timeFrame: 0 to 7 days after beginning of intervention
measure: neuron specific enolase
timeFrame: 0 to 7 days after beginning of intervention
measure: s-100
timeFrame: 0 to 7 days after beginning of intervention
measure: cystatin c
timeFrame: 0 to 7 days after beginning of intervention
measure: galectin-3
timeFrame: 0 to 7 days after beginning of intervention
measure: Duration of: renal replacement therapy (CVVHD), mechanical ventilation, ECMO therapy, inotropic /vasopressor treatment
timeFrame: day 30 after beginning of intervention
measure: 30 day, ICU and in-hospital mortality
timeFrame: day 30 after beginning of intervention
measure: Length of stay in ICU and total length of hospital stay until discharge/transfer
timeFrame: day 30 after beginning of intervention
measure: Necessary Implantation of an Active Assist Device or heart transplantation
timeFrame: day 30 after beginning of intervention
measure: SAPS II
timeFrame: 0 to 7 days after beginning of intervention
measure: APACHE II score
timeFrame: 0 to 7 days after beginning of intervention
measure: SOFA score
timeFrame: 0 to 7 days after beginning of intervention
measure: cerebreal performance category (CPC)
timeFrame: 0 to 30 days after beginning of intervention
measure: Glasgow coma scale (GCS)
timeFrame: 0 to 30 days after beginning of intervention
measure: EuroQuol 5D-3L Descriptive System
timeFrame: 7 to 30 days after beginning of intervention
measure: EQ VAS
timeFrame: 7 to 30 days after beginning of intervention
measure: Modified Rankin scale
timeFrame: 0 to 30 days after beginning of intervention
measure: Measurement of right ventricular parameters
timeFrame: 0 to 7 days after beginning of intervention
measure: Measurement of left ventricular parameters
timeFrame: 0 to 7 days after beginning of intervention
measure: Measurement of kidney injury and kidney function
timeFrame: 0 to 7 days after beginning of intervention
measure: Interleukin 18
timeFrame: 0 to 7 days after beginning of intervention
measure: incidence of apoplexy
timeFrame: 30 days after beginning of intervention
measure: mean arterial pressure
timeFrame: 0 to 7 days after beginning of intervention
measure: central venous oxygen saturation
timeFrame: 0 to 7 days after beginning of intervention
measure: mixed venous oxygen saturation
timeFrame: 0 to 7 days after beginning of intervention
measure: arterial oxygen saturation
timeFrame: 0 to 7 days after beginning of intervention
measure: heart failure re-hospitalisation
timeFrame: 30 days after beginning of intervention
measure: Brain natriuretic peptide (BNP)
timeFrame: 0 to 7 days after beginning of intervention
measure: n-terminal pro brain natriuretic peptide (NT-proBNP)
timeFrame: 0 to 7 days after beginning of intervention
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Jena University Hospital, Department of Cardiology
state: Thuringia
Study officials:
affiliation: Jena University Hospital
name: Christian Schulze, Prof.
role: STUDY_DIRECTOR
References: