Bibliographic Details
| Title: |
Evaluation of the Oxiris Membrane in Cardiogenic Shock Requiring Extracorporeal Membrane Oxygenation Support: Study Protocol for a Single Center, Single-Blind, Randomized Controlled Trial |
| Authors: |
Stefan Andrei, Maxime Nguyen, Vivien Berthoud, Marie-Catherine Morgant, Belaid Bouhemad, Pierre-Grégoire Guinot, The ECMORIX Study Group, Audrey Martin, Mohamed Radhouani, Tiberiu Constandache, Sandrine Grosjean, Pierre Voizeux, Emel Rafrafi, Chloe Bernard, Saed Jazayeri, Ghislain Malapert, Olivier Bouchot |
| Source: |
Frontiers in Cardiovascular Medicine, Vol 8 (2021) |
| Publisher Information: |
Frontiers Media S.A., 2021. |
| Publication Year: |
2021 |
| Collection: |
LCC:Diseases of the circulatory (Cardiovascular) system |
| Subject Terms: |
cardiogenic shock, heart failure, extracorporeal membrane oxygenation, artificial membrane, oxiris, endotoxin/blood, Diseases of the circulatory (Cardiovascular) system, RC666-701 |
| More Details: |
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. |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
2297-055X |
| Relation: |
https://www.frontiersin.org/articles/10.3389/fcvm.2021.738496/full; https://doaj.org/toc/2297-055X |
| DOI: |
10.3389/fcvm.2021.738496 |
| Access URL: |
https://doaj.org/article/9fa7dbba048749afa2ee1f4747cef338 |
| Accession Number: |
edsdoj.9fa7dbba048749afa2ee1f4747cef338 |
| Database: |
Directory of Open Access Journals |
