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NCT Number: NCT05642273

The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with more than 18 years old
  • 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.

  • 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

Exclusion 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 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

Treatment and study plan

oXiris membrane

Device

oXiris membrane for 24h

Blood tests

Diagnostic Test

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

Primary outcomes

  1. Endotoxin level at 48 h

    Time frame: 48 hours after enrollment

    Plasma endotoxin level

Secondary outcomes

  1. Vasoactive-Inotrope score

    Time frame: 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)

  2. Sequential Organ Failure Assessment score

    Time frame: baseline, 24 hours, 48 hours, 72 hours, 96 hours, Day 7

    determine rate of organ failure (higher scores mean a worse outcome)

  3. Plasma cytokines

    Time frame: 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

  4. GDF-15, angiopoietin-2

    Time frame: baseline, 24 hours, 48 hours, Day 7

    endothelial dysfunction

  5. Hospital mortality

    Time frame: at hospital discharge, through study completion, an average 2 months

    death

  6. Neurologic outcome

    Time frame: at hospital discharge, through study completion, an average 2 months

    Cerebral Performance Catergories scale

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

The Effects of extraCorporeal bLood Purification (oXiris ®) in patiEnts With cArdiogeNic Shock Requiring VA-ECMO: A Prospective, Open-label, Randomized Controlled Pilot Study

Acronym: CLEAN ECMO

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2022
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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