Definitions of adverse events associated with extracorporeal membrane oxygenation in children: results of an international Delphi process from the ECMO-CENTRAL ARC.

Autor:	Alexander PMA; Department of Cardiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA., Di Nardo M; Paediatric Intensive Care Unit, Bambino Gesù Children's Hospital, Scientific Institute for Research, Hospitalization and Healthcare, Rome, Italy., Combes A; Service de Médecine Intensive-Réanimation, Institut de Cardiologie, APHP Sorbonne Hôpital Pitié-Salpêtrière, Paris, France., Vogel AM; Michael E DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, USA; Department of Surgery, Texas Children's Hospital, Houston, TX, USA., Antonini MV; Intensive Care Unit, Bufalini Hospital, AUSL della Romagna, Cesena, Italy., Barrett N; Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK; Department of Critical Care and Nephrology, Guy's and St Thomas' NHS Foundation Trust, London, UK., Benedetti GM; Division of Pediatric Neurology, Department of Pediatrics, University of Michigan, Ann Arbor, MI, USA., Bettencourt A; Penn Nursing, University of Pennsylvania, Philadelphia, PA, USA., Brodie D; Department of Medicine, School of Medicine, John Hopkins University, Baltimore, MD, USA., Gómez-Gutiérrez R; TecSalud, University Hospitals School of Medicine, Monterrey Institute of Technology and Higher Education, Monterrey, Mexico., Gorga SM; Division of Pediatric Critical Care Medicine, Department of Pediatrics, University of Michigan, Ann Arbor, MI, USA., Hodgson C; Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia; Intensive Care Unit, Alfred Hospital, Melbourne, VIC, Australia; Department of Critical Care, University of Melbourne, Parkville, VIC, Australia., Kapoor PM; Department of Cardiac Anaesthesia, Cardiothoracic and Neuroscience Centre, All India Institute of Medical Sciences, New Delhi, India., Le J; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, CA, USA., MacLaren G; Cardiothoracic Intensive Care Unit, National University Health System, Singapore., O'Neil ER; Department of Pediatrics, Brooke Army Medical Center, San Antonio, TX, USA; Division of Pediatric Critical Care, Emory University, Atlanta, GA, USA., Ostermann M; Department of Critical Care and Nephrology, Guy's and St Thomas' NHS Foundation Trust, London, UK., Paden ML; Children's Healthcare of Atlanta, Atlanta, GA, USA., Patel N; Neonatal Unit, The Royal Hospital for Children, Glasgow, UK., Rojas-Peña A; Section of Transplantation Surgery, Department of Surgery, University of Michigan, Ann Arbor, MI, USA; Extracorporeal Life Support Lab, Department of Surgery Research, University of Michigan, Ann Arbor, MI, USA., Said AS; Division of Pediatric Critical Care Medicine, St Louis Children's Hospital, Washington University School of Medicine in St Louis, St Louis, MO, USA; Institute for Informatics, Washington University School of Medicine in St Louis, St Louis, MO, USA., Sperotto F; Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA., Willems A; Pediatric Intensive Care Unit, Department of Pediatrics, University Children's Hospital Queen Fabiola-University Hospital of Brussels, Brussels, Belgium., Vercaemst L; Department of Perfusion, University Hospital Gasthuisberg, Leuven, Belgium., Yoganathan AP; Wallace H Coulter Department of Biomedical Engineering, Georgia Institute of Technology, Atlanta, GA, USA., Lorts A; The Heart Institute, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA., Del Nido PJ; Department of Cardiac Surgery, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA., Barbaro RP; Division of Pediatric Critical Care Medicine, Department of Pediatrics, University of Michigan, Ann Arbor, MI, USA; Susan B Meister Child Health Evaluation and Research Center, Division of General Pediatrics, Department of Pediatrics, University of Michigan, Ann Arbor, MI, USA. Electronic address: barbaror@med.umich.edu.
Jazyk:	angličtina
Zdroj:	The Lancet. Child & adolescent health [Lancet Child Adolesc Health] 2024 Oct; Vol. 8 (10), pp. 773-780.
DOI:	10.1016/S2352-4642(24)00132-9
Abstrakt:	Extracorporeal membrane oxygenation (ECMO) is a high-risk and low-volume life support with increasing clinical study. However, heterogenous outcome definitions impede data assimilation into evidence to guide practice. The Academic Research Consortium (ARC), an international collaborative forum committed to facilitating the creation of stakeholder-driven consensus nomenclature and outcomes for clinical trials of medical devices, supported the ECMO Core Elements Needed for Trials Regulation And quality of Life (ECMO-CENTRAL) ARC. The ECMO-CENTRAL ARC was assembled to develop definitions of paediatric ECMO adverse events for use in clinical trials and regulatory device evaluation. An initial candidate list of ECMO adverse events derived from the mechanical circulatory support ARC was supplemented with a review of ECMO-relevant adverse event definitions collated from literature published between Jan 1, 1988, and Feb 20, 2023. Distinct teams of international topic experts drafted separate adverse event definitions that were harmonised to existing literature when appropriate. Draft definitions were revised for paediatric ECMO relevance with input from patients, families, and an international expert panel of trialists, clinicians, statisticians, biomedical engineers, device developers, and regulatory agencies. ECMO-CENTRAL ARC was revised and disseminated across research societies and professional organisations. Up to three rounds of internet-based anonymous surveys were planned as a modified Delphi process. The expert panel defined 13 adverse event definitions: neurological, bleeding, device malfunction, acute kidney injury, haemolysis, infection, vascular access-associated injury, non-CNS thrombosis, hepatic dysfunction, right heart failure, left ventricular overload, lactic acidaemia, and hypoxaemia. Definitional structure varied. Among 165 expert panel members, 114 were eligible to vote and 111 voted. Consensus was achieved for all proposed definitions. Agreement ranged from 82% to 95%. ECMO-CENTRAL ARC paired rigorous development with methodical stakeholder involvement and dissemination to define paediatric ECMO adverse events. These definitions will facilitate new research and the assimilation of data across clinical trials and ECMO device evaluation in children. Competing Interests: Declaration of interests PMAA reports institution funding from the US Department of Defense (PRMRP clinical trial award #W81XWH2210301), National Institutes of Health (NIH R13HD104432), and the US Food and Drug Administration (FDA Grant Number U01FD004979/U01FD005978); and is the Treasurer for Extracorporeal Life Support Organization (ELSO). MDN is a member of the advisory board for Eurosets and a member of the European ELSO Chapter Steering Committee. MVA, NB, and LV are members of the European ELSO Chapter Steering Committee. DB received research support and consulting fees from LivaNova; has been on medical advisory boards for Xenios, Medtronic, Inspira, and Cellenkos; is the President-Elect of ELSO and the Chair of the Executive Committee of the International ECMO Network (ECMONet); and writes for UpToDate. RG-G is a member of the Latin American ELSO Chapter Steering Committee. PMK is a member or the Southwest Asia and Africa ELSO Chapter Steering Committee. GM is President of ELSO. MLP is the Past President of ELSO. AR-P is a consultant for Terumo CVS; and his institution receives funding from the NIH (R01 HL141509 and R01 HL155100). AL is a consultant for Bayer, Abbott, Abiomed, Berlin Heart, and Syncardia; is the primary investigator for the Berlin ACTIVE driver trial; and is an Executive of the ACTION Network. RPB reports a grant from the NIH (R01 HL153519) and is a member of the ELSO Board of Directors and Co-Chair of PediECMO. (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)
Databáze:	MEDLINE
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