The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO

Cardiogenic Shock Clinical Trial

— CLEAN 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05642273
• Other study ID #: CLEAN ECMO
• Status: Completed
• Phase: N/A
• Start date: November 25, 2022
• Est. completion date: January 8, 2024

Study information

• Verified date: March 2024
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 8, 2024
• Est. primary completion date: January 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Intervention

Device:
• oXiris membrane
oXiris membrane for 24h

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endotoxin level at 48 h	Plasma endotoxin level	48 hours after enrollment
Secondary	Vasoactive-Inotrope score	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)	baseline, 24 hours, 48 hours, 72 hours, 96 hours, Day 7
Secondary	Sequential Organ Failure Assessment score	determine rate of organ failure (higher scores mean a worse outcome)	baseline, 24 hours, 48 hours, 72 hours, 96 hours, Day 7
Secondary	Plasma cytokines	IL-6, IL-4, IL-10, TNF-a, IL-1ß/IL-1F2, CCL2/JE/MCP-1, IFN-gamma, IL-8/CXCL8	baseline, 24 hours, 48 hours, Day 7
Secondary	GDF-15, angiopoietin-2	endothelial dysfunction	baseline, 24 hours, 48 hours, Day 7
Secondary	Hospital mortality	death	at hospital discharge, through study completion, an average 2 months
Secondary	Neurologic outcome	Cerebral Performance Catergories scale	at hospital discharge, through study completion, an average 2 months