Evaluation of the Oxiris Membrane in Cardiogenic Shock Requiring Extracorporeal Membrane Oxygenation Support: Study Protocol for a Single Center, Single-Blind, Randomized Controlled Trial

Stefan Andrei; Maxime Nguyen; Vivien Berthoud; Marie-Catherine Morgant; Belaid Bouhemad; Pierre-Grégoire Guinot; ECMORIX Study Group

doi:10.3389/fcvm.2021.738496

Evaluation of the Oxiris Membrane in Cardiogenic Shock Requiring Extracorporeal Membrane Oxygenation Support: Study Protocol for a Single Center, Single-Blind, Randomized Controlled Trial

Front Cardiovasc Med. 2021 Oct 11:8:738496. doi: 10.3389/fcvm.2021.738496. eCollection 2021.

Authors

Stefan Andrei^{1

2}, Maxime Nguyen^{1

3}, Vivien Berthoud¹, Marie-Catherine Morgant⁴, Belaid Bouhemad^{1

3}, Pierre-Grégoire Guinot^{1

3}; ECMORIX Study Group

Collaborators

ECMORIX Study Group:
Audrey Martin, Mohamed Radhouani, Tiberiu Constandache, Sandrine Grosjean, Pierre Voizeux, Emel Rafrafi, Chloe Bernard, Saed Jazayeri, Ghislain Malapert, Olivier Bouchot

Affiliations

¹ Anaesthesiology and Critical Care Department, Dijon Bourgogne University Hospital, Dijon, France.
² Anaesthesiology and Critical Care Department, Carol Davila University of Medicine, Bucharest, Romania.
³ University of Burgundy Franche Comté, Dijon, France.
⁴ Cardiac Surgical Department, Dijon Bourgogne University Hospital, Dijon, France.

Abstract

Background: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is the rescue treatment proposed to patients with refractory cardiogenic shock. The VA-ECMO implantation promotes inflammation and ischemia-reperfusion injuries through the VA-ECMO flow, causing digestive mucosa barrier disrupture and inducing translocation of bacterial wall components-Lipopolysaccharides (LPS) with further inflammation and circulatory impairment. LPS is a well-studied surrogate indicator of bacterial translocation. Oxiris membrane is a promising and well-tolerated device that can specifically remove LPS. The main study aim is to compare the LPS elimination capacity of Oxiris membrane vs. a non-absorbant classical renal replacement (RRT) membrane in patients with cardiogenic shock requiring VA-ECMO. Methods: ECMORIX is a randomized, prospective, single-center, single-blind, parallel-group, controlled study. It compares the treatment with Oxiris membrane vs. the standard continuous renal replacement therapy care in patients with cardiogenic shock support by peripheral VA-ECMO. Forty patients will be enrolled in both treatment groups. The primary endpoint is the value of LPS serum levels after 24 h of treatment. LPS serum levels will be monitored during the first 72 h of treatment, as clinical and cardiac ultrasound parameters, biological markers of inflammation and 30-day mortality. Discussion: Oxiris membrane appears to be beneficial in controlling the VA-ECMO-induced ischemia-reperfusion inflammation by LPS removal. ECMORIX results will be of major importance in the management of severe cases requiring VA-ECMO and will bring pathophysiological insights about the LPS role in this context. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04886180.

Keywords: artificial membrane; cardiogenic shock; continuous renal replacement therapy; cytokines/blood; endotoxin/blood; extracorporeal membrane oxygenation; heart failure; oxiris.

Associated data

ClinicalTrials.gov/NCT04886180