• Thomas L Klitgaard, Olav L Schjørring, Theis Lange, MøllerMorten HylanderMH0000-0002-6378-9673Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.Department of Intensive Care 4131, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark., Anders Perner, Bodil S Rasmussen, and Anders Granholm.
• Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.
• Acta Anaesthesiol Scand. 2020 Oct 1; 64 (9): 1376-1381.

BackgroundThe Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU) trial is an ongoing randomised clinical trial exploring the benefits and harms of targeting a lower (8 kPa) versus a higher (12 kPa) arterial oxygenation target in adult patients acutely admitted to the intensive care unit (ICU) with hypoxaemic respiratory failure.MethodsThis protocol describes a secondary analysis of the primary trial outcome, 90-day all-cause mortality. We will analyse the primary outcome using Bayesian methods, which allows quantification of probabilities of all effect sizes. We will explore the presence of heterogeneity of treatment effects (HTE) using Bayesian hierarchical models in subgroups based on baseline parameters: (a) severity of illness (Sequential Organ Failure Assessment (SOFA) score), (b) severity of hypoxaemic respiratory failure (partial pressure of arterial oxygen (PaO2 )/fraction of inspired oxygen (FiO2 ) ratio), (c) vasopressor requirement (highest noradrenaline dose in the 24 hours prior to randomisation), and (d) plasma lactate concentration (latest prior to randomisation). Additionally, we will perform separate assessments of the treatment effect interaction with each of the baseline parameters above on the continuous scale and present these using conditional effects plots.ConclusionsThis secondary analysis will aid the interpretation of the HOT-ICU trial by evaluating probabilities of all effect sizes. In addition, we will evaluate whether HTE is present, thus, further evaluating benefits and harms of a lower versus a higher oxygenation target in adult ICU patients with acute hypoxaemic respiratory failure.© 2020 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

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