Handling oxygenation targets in ICU patients with COVID-19 - protocol and statistical analysis plan in the HOT-COVID trial

Frederik Mølgaard Nielsen*, Thomas Lass Klitgaard, Elena Crescioli, Søren Rosborg Aagaard, Anne Sofie Andreasen, Lone Musaeus Poulsen, Martin Siegemund, Anne Craveiro Brøchner, Morten Heiberg Bestle, Susanne Andi Iversen, Björn Anders Brand, Jon Henrik Laake, Thorbjørn Grøfte, Thomas Hildebrandt, Theis Lange, Anders Perner, Olav Lilleholt Schjørring, Bodil Steen Rasmussen

*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskriftProtokolpeer review

Abstract

BACKGROUND: Coronavirus disease (COVID-19) primarily affects the lungs and lower airways and may present as hypoxaemic respiratory failure requiring admission to an intensive care unit (ICU) for supportive treatment. Here, supplemental oxygen remains essential for COVID-19 patient management, but the optimal dosage is not defined. We hypothesize that targeting an arterial partial pressure of oxygen of 8 kPa throughout ICU admission is superior to targeting 12 kPa.

METHODS: The Handling Oxygenation Targets in ICU patients with COVID-19 (HOT-COVID) trial, is an investigator-initiated, pragmatic, multicentre, randomized, parallel-group trial comparing a lower oxygenation target versus a higher oxygenation target in adult ICU patients with COVID-19. The primary outcome is days alive without life-support (use of mechanical ventilation, renal replacement therapy or vasoactive therapy) at day 90. Secondary outcomes are 90-day and 1-year mortality, serious adverse events in the ICU and days alive and out of hospital in the 90-day period, health-related quality-of-life at 1 year, and health economic analyses. One-year follow-up of cognitive and pulmonary function is planned in a subgroup of Danish patients. We will include 780 patients to detect or reject an absolute increase in days alive without life-support of 7 days with an α of 5% and a β of 20%. An interim analysis is planned after 90-day follow-up of 390 patients.

CONCLUSIONS: The HOT-COVID trial will provide patient-important data on the effect of two oxygenation targets in ICU patients with COVID-19 and hypoxia. This protocol paper describes the background, design and statistical analysis plan for the trial.

OriginalsprogEngelsk
Sider (fra-til)1497-1504
Antal sider8
TidsskriftActa Anaesthesiologica Scandinavica
Vol/bind65
Udgave nummer10
Tidlig onlinedato26 jul. 2021
DOI
StatusUdgivet - nov. 2021

Bibliografisk note

© 2021 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

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