Blend to Limit OxygEN in ECMO: A RanDomised ControllEd Registry (BLENDER) Trial: Study Protocol and Statistical Analysis Plan.
Cardiogenic shock
Extracorporeal membrane oxygenation
Hyperoxia
Ischaemic reperfusion injury
Venoarterial
Journal
Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine
ISSN: 1441-2772
Titre abrégé: Crit Care Resusc
Pays: Netherlands
ID NLM: 100888170
Informations de publication
Date de publication:
Sep 2023
Sep 2023
Historique:
medline:
25
10
2023
pubmed:
25
10
2023
entrez:
25
10
2023
Statut:
epublish
Résumé
Critically ill patients supported with venoarterial extracorporeal membrane oxygenation (VA ECMO) are at risk of developing severe arterial hyperoxia, which has been associated with increased mortality. Lower saturation targets in this population may lead to deleterious episodes of severe hypoxia. This manuscript describes the protocol and statistical analysis plan for the Blend to Limit OxygEN in ECMO: A RanDomised ControllEd Registry (BLENDER) Trial. The BLENDER trial is a pragmatic, multicentre, registry-embedded, randomised clinical trial., registered at ClinicalTrials.gov (NCT03841084) and approved by The Alfred Hospital Ethics Committee project ID HREC/50486/Alfred-2019. Patients supported by VA ECMO for cardiogenic shock or cardiac arrest who are enrolled in the Australian national ECMO registry. The study compares a conservative oxygenation strategy (target arterial saturations 92-96%) with a liberal oxygenation strategy (target 97-100%). The primary outcome is the number of intensive care unit (ICU)-free days for patients alive at day 60. Secondary outcomes include duration of mechanical ventilation, ICU and hospital mortality, the number of hypoxic episodes, neurocognitive outcomes, and health economic analyses. The 300-patient sample size enables us to detect a 3-day difference in ICU-free days at day 60, assuming a mean ICU-free days of 11 days, with a risk of type 1 error of 5% and power of 80%. Data will be analysed according to a predefined analysis plan. Findings will be disseminated in peer-reviewed publications. This paper details the protocol and statistical analysis plan for the BLENDER trial, a registry-embedded, multicentre interventional trial comparing liberal and conservative oxygenation strategies in VA ECMO.
Identifiants
pubmed: 37876374
doi: 10.1016/j.ccrj.2023.06.001
pii: S1441-2772(23)00022-4
pmc: PMC10581278
doi:
Banques de données
ClinicalTrials.gov
['NCT03841084']
Types de publication
Journal Article
Langues
eng
Pagination
118-125Informations de copyright
© 2023 The Authors.
Déclaration de conflit d'intérêts
Authors Rinaldo Bellomo, David Pilcher, Carol Hodgson, Andrew Udy and Ed Litton declare a conflict of interest as Editors of this journal.
Références
N Engl J Med. 2021 Apr 8;384(14):1301-1311
pubmed: 33471452
Crit Care Med. 2015 Jul;43(7):1508-19
pubmed: 25855899
Crit Care. 2014 Dec 23;18(6):711
pubmed: 25532567
J Crit Care. 2022 Jun;69:154001
pubmed: 35217372
Crit Care Resusc. 2012 Sep;14(3):211-5
pubmed: 22963216
Ann Intensive Care. 2015 Dec;5(1):42
pubmed: 26585328
N Engl J Med. 2022 Nov 10;387(19):1759-1769
pubmed: 36278971
Respirology. 2015 Nov;20(8):1182-91
pubmed: 26486092
N Engl J Med. 2020 Mar 12;382(11):999-1008
pubmed: 32160661
J Postgrad Med. 2001 Oct-Dec;47(4):264-7
pubmed: 11832645
J Clin Epidemiol. 2010 Aug;63(8):e1-37
pubmed: 20346624
Crit Care Resusc. 2013 Sep;15(3):179-85
pubmed: 23944203
Crit Care Med. 2017 Dec;45(12):1997-2005
pubmed: 28787294
Aust Crit Care. 2021 Jan;34(1):55-59
pubmed: 32620254
Crit Care. 2022 Aug 26;26(1):257
pubmed: 36028883
JAMA. 2022 Nov 8;328(18):1818-1826
pubmed: 36286192
N Engl J Med. 2020 Mar 12;382(11):989-998
pubmed: 31613432
J Biomed Inform. 2019 Jul;95:103208
pubmed: 31078660