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The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO

NCT05642273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-03-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Jeong Hoon Yang, MD, PhD · Department of Critical Care Medicine, Samsung Medical Center, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-25
Primary Completion
2024-01-08
Completion
2024-01-08

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05642273 on ClinicalTrials.gov