NCT05642273

The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-11-25
• Primary completion: 2024-01-08
• Completion: 2024-01-08
• First posted: 2022-12-08
• Last updated: 2024-03-29

Locations

1 site across 1 country: South Korea