PMID- 34708091
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240403
IS  - 2297-055X (Print)
IS  - 2297-055X (Electronic)
IS  - 2297-055X (Linking)
VI  - 8
DP  - 2021
TI  - Evaluation of the Oxiris Membrane in Cardiogenic Shock Requiring Extracorporeal 
      Membrane Oxygenation Support: Study Protocol for a Single Center, Single-Blind, 
      Randomized Controlled Trial.
PG  - 738496
LID - 10.3389/fcvm.2021.738496 [doi]
LID - 738496
AB  - 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.
CI  - Copyright (c) 2021 Andrei, Nguyen, Berthoud, Morgant, Bouhemad, Guinot and the 
      ECMORIX Study Group.
FAU - Andrei, Stefan
AU  - Andrei S
AD  - Anaesthesiology and Critical Care Department, Dijon Bourgogne University 
      Hospital, Dijon, France.
AD  - Anaesthesiology and Critical Care Department, Carol Davila University of 
      Medicine, Bucharest, Romania.
FAU - Nguyen, Maxime
AU  - Nguyen M
AD  - Anaesthesiology and Critical Care Department, Dijon Bourgogne University 
      Hospital, Dijon, France.
AD  - University of Burgundy Franche Comte, Dijon, France.
FAU - Berthoud, Vivien
AU  - Berthoud V
AD  - Anaesthesiology and Critical Care Department, Dijon Bourgogne University 
      Hospital, Dijon, France.
FAU - Morgant, Marie-Catherine
AU  - Morgant MC
AD  - Cardiac Surgical Department, Dijon Bourgogne University Hospital, Dijon, France.
FAU - Bouhemad, Belaid
AU  - Bouhemad B
AD  - Anaesthesiology and Critical Care Department, Dijon Bourgogne University 
      Hospital, Dijon, France.
AD  - University of Burgundy Franche Comte, Dijon, France.
FAU - Guinot, Pierre-Gregoire
AU  - Guinot PG
AD  - Anaesthesiology and Critical Care Department, Dijon Bourgogne University 
      Hospital, Dijon, France.
AD  - University of Burgundy Franche Comte, Dijon, France.
CN  - ECMORIX Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT04886180
PT  - Journal Article
DEP - 20211011
PL  - Switzerland
TA  - Front Cardiovasc Med
JT  - Frontiers in cardiovascular medicine
JID - 101653388
PMC - PMC8544809
OTO - NOTNLM
OT  - artificial membrane
OT  - cardiogenic shock
OT  - continuous renal replacement therapy
OT  - cytokines/blood
OT  - endotoxin/blood
OT  - extracorporeal membrane oxygenation
OT  - heart failure
OT  - oxiris
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
FIR - Martin, Audrey
IR  - Martin A
FIR - Radhouani, Mohamed
IR  - Radhouani M
FIR - Constandache, Tiberiu
IR  - Constandache T
FIR - Grosjean, Sandrine
IR  - Grosjean S
FIR - Voizeux, Pierre
IR  - Voizeux P
FIR - Rafrafi, Emel
IR  - Rafrafi E
FIR - Bernard, Chloe
IR  - Bernard C
FIR - Jazayeri, Saed
IR  - Jazayeri S
FIR - Malapert, Ghislain
IR  - Malapert G
FIR - Bouchot, Olivier
IR  - Bouchot O
EDAT- 2021/10/29 06:00
MHDA- 2021/10/29 06:01
PMCR- 2021/01/01
CRDT- 2021/10/28 06:42
PHST- 2021/07/08 00:00 [received]
PHST- 2021/09/20 00:00 [accepted]
PHST- 2021/10/28 06:42 [entrez]
PHST- 2021/10/29 06:00 [pubmed]
PHST- 2021/10/29 06:01 [medline]
PHST- 2021/01/01 00:00 [pmc-release]
AID - 10.3389/fcvm.2021.738496 [doi]
PST - epublish
SO  - Front Cardiovasc Med. 2021 Oct 11;8:738496. doi: 10.3389/fcvm.2021.738496. 
      eCollection 2021.