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Higher versus lower oxygenation targets in COVID-19 patients with severe hypoxaemia (HOT-COVID) trial: Protocol for a secondary Bayesian analysis.
Mølgaard Nielsen, Frederik; Lass Klitgaard, Thomas; Granholm, Anders; Lange, Theis; Perner, Anders; Lilleholt Schjørring, Olav; Steen Rasmussen, Bodil.
Affiliation
  • Mølgaard Nielsen F; Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.
  • Lass Klitgaard T; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
  • Granholm A; Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
  • Lange T; Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.
  • Perner A; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
  • Lilleholt Schjørring O; Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
  • Steen Rasmussen B; Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Acta Anaesthesiol Scand ; 66(3): 408-414, 2022 03.
Article in En | MEDLINE | ID: mdl-34951717
BACKGROUND: Respiratory failure is the main cause of mortality and morbidity among ICU patients with coronavirus disease 2019 (COVID-19). In these patients, supplemental oxygen therapy is essential, but there is limited evidence the optimal target. To address this, the ongoing handling oxygenation targets in COVID-19 (HOT-COVID) trial was initiated to investigate the effect of a lower oxygenation target (partial pressure of arterial oxygen (PaO2 ) of 8 kPa) versus a higher oxygenation target (PaO2 of 12 kPa) in the ICU on clinical outcome in patients with COVID-19 and hypoxaemia. METHODS: The HOT-COVID is planned to enrol 780 patients. This paper presents the protocol and statistical analysis plan for the conduct of a secondary Bayesian analysis of the primary outcome of HOT-COVID being days alive without life-support at 90 days and the secondary outcome 90-day all-cause mortality. Furthermore, both outcomes will be investigated for the presence heterogeneity of treatment effects based on four baseline parameters being sequential organ failure assessment score, PaO2 /fraction of inspired oxygen ratio, highest dose of norepinephrine during the 24 h before randomisation, and plasma concentration of lactate at randomisation. CONCLUSION: The results of this pre-planned secondary Bayesian analysis will complement the primary frequentist analysis of the HOT-COVID trial and may facilitate a more nuanced interpretation of the trial results.
Subject(s)

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Respiratory Insufficiency / COVID-19 Type of study: Clinical_trials / Guideline / Prognostic_studies Limits: Humans Language: En Journal: Acta Anaesthesiol Scand Year: 2022 Document type: Article Affiliation country: Denmark Country of publication: United kingdom

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Respiratory Insufficiency / COVID-19 Type of study: Clinical_trials / Guideline / Prognostic_studies Limits: Humans Language: En Journal: Acta Anaesthesiol Scand Year: 2022 Document type: Article Affiliation country: Denmark Country of publication: United kingdom