Cardiogenic Shock
Conditions
Keywords
cardiogenic shock, venoarterial extracorporeal membrane oxygenation, endotoxin, cytokine, oXiris
Brief summary
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.
Interventions
DEVICEoXiris membrane
oXiris membrane for 24h
DIAGNOSTIC_TESTBlood tests
Blood tests just after randomization (0 h) and at 24 h, 48 h and 7 days
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with more than 18 years old 2. 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. 3. Patients receiving VA ECMO owing related to the causes listed in 2-1, 2-2, 2-3. 4. Written informed consent from patient or legal surrogates
Exclusion criteria
1. Other causes except for CS: septic shock, cardiac arrest by serious ventricular arrhythmia mot related to the myocardial ischemia or heart failure. 2. Shock with unwitnessed cardiac arrest outside the hospital 3. Severe non-cardiac morbidity with expected survival less than 6 months (malignancy, respiratory failure) 4. Suspicious of brain death 5. Those who refused active treatment 6. Body weight under 30 kg 7. Heparin allergy 8. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endotoxin level at 48 h | 48 hours after enrollment | Plasma endotoxin level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sequential Organ Failure Assessment score | baseline, 24 hours, 48 hours, 72 hours, 96 hours, Day 7 | determine rate of organ failure (higher scores mean a worse outcome) |
| Plasma cytokines | baseline, 24 hours, 48 hours, Day 7 | IL-6, IL-4, IL-10, TNF-α, IL-1β/IL-1F2, CCL2/JE/MCP-1, IFN-gamma, IL-8/CXCL8 |
| Vasoactive-Inotrope score | baseline, 24 hours, 48 hours, 72 hours, 96 hours, Day 7 | 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) |
| Hospital mortality | at hospital discharge, through study completion, an average 2 months | death |
| Neurologic outcome | at hospital discharge, through study completion, an average 2 months | Cerebral Performance Catergories scale |
| GDF-15, angiopoietin-2 | baseline, 24 hours, 48 hours, Day 7 | endothelial dysfunction |
Countries
South Korea
Outcome results
None listed