The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO (CLEAN ECMO)

Samsung Medical Center

Status: Completed

Conditions: Cardiogenic Shock

Treatments: Diagnostic Test: Blood tests; Device: oXiris membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT05642273

CLEAN ECMO

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intervention

Experimental group

Description:

Oxiris for 24 h

Treatment:

Device: oXiris membrane

Diagnostic Test: Blood tests

Control

Active Comparator group

Description:

Usual care

Treatment:

Diagnostic Test: Blood tests