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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
oXiris membrane for 24h
Blood tests just after randomization (0 h) and at 24 h, 48 h and 7 days
Samsung Medical Center
Seoul, South Korea
Endotoxin level at 48 h
Plasma endotoxin level
Time frame: 48 hours after enrollment
Vasoactive-Inotrope score
VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10,000 × vasopressin (units/kg/min) + 50 × levosimendan (µg/kg/min)
Time frame: baseline, 24 hours, 48 hours, 72 hours, 96 hours, Day 7
Sequential Organ Failure Assessment score
determine rate of organ failure (higher scores mean a worse outcome)
Time frame: baseline, 24 hours, 48 hours, 72 hours, 96 hours, Day 7
Plasma cytokines
IL-6, IL-4, IL-10, TNF-α, IL-1β/IL-1F2, CCL2/JE/MCP-1, IFN-gamma, IL-8/CXCL8
Time frame: baseline, 24 hours, 48 hours, Day 7
GDF-15, angiopoietin-2
endothelial dysfunction
Time frame: baseline, 24 hours, 48 hours, Day 7
Hospital mortality
death
Time frame: at hospital discharge, through study completion, an average 2 months
Neurologic outcome
Cerebral Performance Catergories scale
Time frame: at hospital discharge, through study completion, an average 2 months
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