The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO

Study Overview
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Brief Summary
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Cardiogenic shock (CS) defines a state of systemic hypo-perfusion leading to end-organ dysfunction related to cardiac pump failure and with mortality rates in the range of 27-50% according to recent reviews. Patients with CS often received mechanical circulatory support, and venoarterial extracorporeal membrane oxygenator (V-A ECMO) is an effective tool to support refractory CS while ensuring continuous organ perfusion. Patients with CS present clinical signs of systemic inflammation and elevated plasma levels of prototypical inflammatory and vasoactive mediators, including C-reactive protein (CRP), Interleukin-6 (IL-6) and tumor necrosis factor alpha (TNFα). As data is scarce in this field, we decided to perform a prospective randomized controlled pilot study to investigate the efficacy of extracorporeal cytokine and lipopolysaccharide adsorption using Oxiris on humoral inflammation parameters, hemodynamics, and clinical outcomes in patients with CS requiring VA ECMO.

Official Title
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The Effects of extraCorporeal bLood Purification (oXiris ®) in patiEnts With cArdiogeNic Shock Requiring VA-ECMO: A Prospective, Open-label, Randomized Controlled Pilot Study

Conditions
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Cardiogenic Shock

Intervention / Treatment
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* Device: oXiris membrane
* Diagnostic Test: Blood tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with more than 18 years old CS is defined as the presence of the following: 2-1) Systolic blood pressure is less than 90 mmHg for more than 30 minutes despite the fluid therapy, or the use of pressure boosting agents to maintain the systolic blood pressure more than 90 mmHg. 2-2) Peripheral hypoperfusion (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol/l) or a person with pulmonary edema. 2-3) Causes of CS include ischemic (acute myocardial infarction or ischemic cardiomyopathy, shock during percutaneous coronary intervention), myocardial (end-stage heart failure, myocarditis), post-cardiotomy shock, cardiac tamponade, or pulmonary thromboembolism. Patients receiving VA ECMO owing related to the causes listed in 2-1, 2-2, 2-3. Written informed consent from patient or legal surrogates Exclusion Criteria: Other causes except for CS: septic shock, cardiac arrest by serious ventricular arrhythmia mot related to the myocardial ischemia or heart failure. Shock with unwitnessed cardiac arrest outside the hospital Severe non-cardiac morbidity with expected survival less than 6 months (malignancy, respiratory failure) Suspicious of brain death Those who refused active treatment body weight under 30 kg Heparin allergy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Oxiris for 24 h | Device: oXiris membrane<br>* oXiris membrane for 24h<br>Diagnostic Test: Blood tests<br>* Blood tests just after randomization (H0) and at H24, H48 and 7 days<br>|
| Active Comparator: Control<br>Usual care | Diagnostic Test: Blood tests<br>* Blood tests just after randomization (H0) and at H24, H48 and 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VIS day 0 and day 2 | VIS, Vasoactive Inotropic Score; dopamine dose (mg/kg/min) + dobutamine dose (mg/kg/min) + 100 x epinephrine dose (mg/kg/ min) + 10 x milrinone dose (mg/kg/min) + 10,000 x vasopressin dose (unit/kg/min) + 100 x norepinephrine dose (mg/kg/min); A high score indicates the use of a high-dose vasoactive agent. | day 0 and day 2 |