Clinical trial NCT05642273: The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO
Official title: The Effects of extraCorporeal bLood Purification (oXiris ®) in patiEnts With cArdiogeNic Shock Requiring VA-ECMO: A Prospective, Open-label, Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiogenic Shock
Keywords: cardiogenic shock
venoarterial extracorporeal membrane oxygenation
endotoxin
cytokine
oXiris
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Endotoxin level at 48 h
timeFrame: 48 hours after enrollment
Secondary outcomes:
measure: Vasoactive-Inotrope score
timeFrame: baseline, 24 hours, 48 hours, 72 hours, 96 hours, Day 7
measure: Sequential Organ Failure Assessment score
timeFrame: baseline, 24 hours, 48 hours, 72 hours, 96 hours, Day 7
measure: Plasma cytokines
timeFrame: baseline, 24 hours, 48 hours, Day 7
measure: GDF-15, angiopoietin-2
timeFrame: baseline, 24 hours, 48 hours, Day 7
measure: Hospital mortality
timeFrame: at hospital discharge, through study completion, an average 2 months
measure: Neurologic outcome
timeFrame: at hospital discharge, through study completion, an average 2 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Department of Critical Care Medicine, Samsung Medical Center, Korea
name: Jeong Hoon Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: