Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/34128
Title: Blend to Limit OxygEN in ECMO: A RanDomised ControllEd Registry (BLENDER) Trial: Study Protocol and Statistical Analysis Plan.
Austin Authors: Burrell, Aidan;Ng, Sze;Ottosen, Kelly;Bailey, Michael;Buscher, Hergen;Fraser, John;Udy, Andrew;Gattas, David;Totaro, Richard;Bellomo, Rinaldo ;Forrest, Paul;Martin, Emma;Reid, Liadain;Ziegenfuss, Marc;Eastwood, Glenn M ;Higgins, Alisa;Hodgson, Carol;Litton, Edward;Nair, Priya;Orford, Neil;Pellegrino, Vince;Shekar, Kiran;Trapani, Tony;Pilcher, David
Affiliation: Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.;Department of Intensive Care and Hyperbaric Medicine, The Alfred, Melbourne, VIC, Australia.
Data Analytics Research and Evaluation (DARE) Centre
Department of Critical Care, School of Medicine, University of Melbourne, VIC, Australia.
Intensive Care
Critical Care Research Group, Brisbane, QLD, Australia.;Faculty of Medicine, The University of Queensland, Brisbane, QLD, Australia.
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.;Department of Intensive Care and Hyperbaric Medicine, The Alfred, Melbourne, VIC, Australia.
Intensive Care Unit, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.;Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
Department of Critical Care, School of Medicine, University of Melbourne, VIC, Australia.;Data Analytics Research and Evaluation (DARE) Centre, Austin Hospital, Melbourne, VIC, Australia.
Sydney Medical School, University of Sydney, Sydney, NSW, Australia.;Department of Anaesthetics, Royal Prince Alfred Hospital, Sydney, NSW, Australia.
Department of Intensive Care and Hyperbaric Medicine, The Alfred, Melbourne, VIC, Australia.
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Adult Intensive Care Unit, The Prince Charles Hospital, Brisbane, QLD, Australia.
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.;Department of Intensive Care, Austin Hospital, Melbourne, VIC, Australia.
Department of Critical Care, School of Medicine, University of Melbourne, VIC, Australia.
Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA, Australia.
Intensive Care Unit, St Vincent's Hospital, Darlinghurst, NSW, Australia.
Intensive Care Unit, University Hospital Geelong, Barwon Health, Geelong, VIC, Australia.;School of Medicine, Deakin University, Waurn Ponds, VIC, Australia.
Department of Intensive Care and Hyperbaric Medicine, The Alfred, Melbourne, VIC, Australia.
Faculty of Medicine, The University of Queensland, Brisbane, QLD, Australia.;Adult Intensive Care Unit, The Prince Charles Hospital, Brisbane, QLD, Australia.
Issue Date: Sep-2023
Date: 2023
Publication information: Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine 2023-09; 25(3)
Abstract: 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.
URI: https://ahro.austin.org.au/austinjspui/handle/1/34128
DOI: 10.1016/j.ccrj.2023.06.001
ORCID: 
Journal: Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine
Start page: 118
End page: 125
PubMed URL: 37876374
Type: Journal Article
Subjects: Cardiogenic shock
Extracorporeal membrane oxygenation
Hyperoxia
Ischaemic reperfusion injury
Venoarterial
Appears in Collections:Journal articles

Show full item record

Page view(s)

38
checked on Apr 15, 2024

Google ScholarTM

Check


Items in AHRO are protected by copyright, with all rights reserved, unless otherwise indicated.