Blend to Limit OxygEN in ECMO: A RanDomised ControllEd Registry (BLENDER) Trial: Study Protocol and Statistical Analysis Plan.

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

doi:10.1016/j.ccrj.2023.06.001

Title

Blend to Limit OxygEN in ECMO: A RanDomised ControllEd Registry (BLENDER) Trial: Study Protocol and Statistical Analysis Plan.

Publication Date

2023-09

Author(s)

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

Subject

Cardiogenic shock

Extracorporeal membrane oxygenation

Hyperoxia

Ischaemic reperfusion injury

Venoarterial

Type of document

Journal Article

OrcId

#PLACEHOLDER_PARENT_METADATA_VALUE#

DOI

10.1016/j.ccrj.2023.06.001

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.

Link

link

Citation

Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine 2023-09; 25(3)

Jornal Title

Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine

Austin Health

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