Andrei Stefan, Nguyen Maxime, Berthoud Vivien, Morgant Marie-Catherine, Bouhemad Belaid, Guinot Pierre-Grégoire
Anaesthesiology and Critical Care Department, Dijon Bourgogne University Hospital, Dijon, France.
Anaesthesiology and Critical Care Department, Carol Davila University of Medicine, Bucharest, Romania.
Front Cardiovasc Med. 2021 Oct 11;8:738496. doi: 10.3389/fcvm.2021.738496. eCollection 2021.
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. 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. 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. www.ClinicalTrials.gov, identifier: NCT04886180.
静脉-动脉体外膜肺氧合（VA-ECMO）是针对难治性心源性休克患者提出的抢救治疗方法。VA-ECMO植入通过VA-ECMO血流促进炎症和缺血-再灌注损伤，导致消化黏膜屏障破坏，并诱导细菌壁成分脂多糖（LPS）移位，进而引发进一步的炎症和循环障碍。LPS是一种经过充分研究的细菌移位替代指标。Oxiris膜是一种有前景且耐受性良好的装置，能够特异性清除LPS。主要研究目的是比较Oxiris膜与非吸附性经典肾脏替代（RRT）膜对需要VA-ECMO的心源性休克患者的LPS清除能力。ECMORIX是一项随机、前瞻性、单中心、单盲、平行组对照研究。它比较了Oxiris膜治疗与标准持续肾脏替代治疗对接受外周VA-ECMO支持的心源性休克患者的疗效。两个治疗组将各纳入40例患者。主要终点是治疗24小时后LPS血清水平的值。在治疗的前72小时内将监测LPS血清水平，以及临床和心脏超声参数、炎症生物标志物和30天死亡率。Oxiris膜似乎通过清除LPS有助于控制VA-ECMO诱导的缺血-再灌注炎症。ECMORIX的结果对于需要VA-ECMO的重症病例的管理至关重要，并将为LPS在此背景下的作用带来病理生理学见解。ClinicalTrials.gov网站，标识符：NCT04886180。
