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NCT05642273
The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO
Conditions: Cardiogenic Shock
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 60
Sponsor: Samsung Medical Center
Location: Korea, Republic of
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.
Eligibility Criteria
Inclusion Criteria:Patients with more than 18 years oldCS 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 surrogatesExclusion 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 hospitalSevere non-cardiac morbidity with expected survival less than 6 months (malignancy, respiratory failure)Suspicious of brain deathThose who refused active treatmentbody weight under 30 kgHeparin allergy
Source: ClinicalTrials.gov (NCT05642273). StuddyBuddy aggregates publicly available trial information.