The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO

NCT05642273 | Completed

• 1 other identifier: CLEAN ECMO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiogenic Shock

Keywords

cardiogenic shock; venoarterial extracorporeal membrane oxygenation; endotoxin; cytokine; oXiris

Outcome Measures

Primary Outcomes (1)

• Endotoxin level at 48 h

  Plasma endotoxin level

  48 hours after enrollment

Secondary Outcomes (6)

• Vasoactive-Inotrope score

  baseline, 24 hours, 48 hours, 72 hours, 96 hours, Day 7

• Sequential Organ Failure Assessment score

  baseline, 24 hours, 48 hours, 72 hours, 96 hours, Day 7

• Plasma cytokines

  baseline, 24 hours, 48 hours, Day 7

• GDF-15, angiopoietin-2

  baseline, 24 hours, 48 hours, Day 7

• Hospital mortality

  at hospital discharge, through study completion, an average 2 months

Study Arms (2)

Intervention

EXPERIMENTAL

Oxiris for 24 h

Device: oXiris membrane; Diagnostic Test: Blood tests

Control

ACTIVE COMPARATOR

Usual care

Diagnostic Test: Blood tests

Interventions

oXiris membrane DEVICE

oXiris membrane for 24h

Intervention

Blood tests DIAGNOSTIC_TEST

Blood tests just after randomization (0 h) and at 24 h, 48 h and 7 days

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with more than 18 years old
• CS is defined as the presence of the following:
• ) 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.
• ) Peripheral hypoperfusion (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol/l) or a person with pulmonary edema.
• ) 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 surrogates

You may not qualify if:

• 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 hospital
• Severe non-cardiac morbidity with expected survival less than 6 months (malignancy, respiratory failure)
• Suspicious of brain death
• Those who refused active treatment
• Body weight under 30 kg
• Heparin allergy
• Pregnancy

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (1)

• Ko RE, Choi KH, Lee K, Jeon J, Jang HR, Chung CR, Cho YH, Park TK, Lee JM, Song YB, Hahn JY, Choi SH, Gwon HC, Yang JH. The effects of extracorporeal blood purification (oXiris(R)) in patients with cardiogenic shock who require VA-ECMO (CLEAN ECMO): a prospective, open-label, randomized controlled pilot study. Crit Care. 2025 Jun 20;29(1):255. doi: 10.1186/s13054-025-05495-4.

  PMID: 40542431 DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Jeong Hoon Yang, MD, PhD

  Department of Critical Care Medicine, Samsung Medical Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 8, 2022
• Study Start: November 25, 2022
• Primary Completion: January 8, 2024
• Study Completion: January 8, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)