tetano
Editor, Senior Moderator
Chest
. 2024 Sep 18:S0012-3692(24)05164-X.
doi: 10.1016/j.chest.2024.08.055. Online ahead of print. Lower or Higher Oxygenation Targets in ICU patients with COVID-19 - A secondary Bayesian analysis of the HOT-COVID trial
Frederik M Nielsen[SUP] 1 [/SUP], Thomas L Klitgaard[SUP] 2 [/SUP], Anders Granholm[SUP] 3 [/SUP], Theis Lange[SUP] 4 [/SUP], Anders Perner[SUP] 5 [/SUP], Olav L Schjørring[SUP] 2 [/SUP], Bodil S Rasmussen[SUP] 2 [/SUP]
Affiliations
Background: In the Handling Oxygenation Targets in COVID-19 (HOT-COVID) trial, a partial pressure of arterial oxygen (PaO[SUB]2[/SUB]) target of 60 mmHg compared to 90 mmHg resulted in more days alive without life support at 90 days in adult ICU patients with coronavirus disease 2019 (COVID-19) and hypoxemia. The trial was stopped after enrolling 726 of 780 planned patients due to slow recruitment. Here, we present the preplanned Bayesian analysis of the HOT-COVID trial.
Research question: What are the probabilities of any and of clinically relevant benefits from a PaO[SUB]2[/SUB] target of 60 mmHg versus 90 mmHg in adult ICU patients with COVID-19 and hypoxemia, and is there heterogeneity of treatment effects (HTE) according to selected baseline characteristics?
Study design: and Methods We analyzed days alive without life support and 90-day mortality in the HOT-COVID intention-to-treat population (n=697) using Bayesian general linear models to assess probabilities for benefit or harm, including clinically relevant benefits defined as >1 day alive without life support and >2 percentage points lower 90-day mortality. HTE was evaluated based on baseline SOFA scores, PaO[SUB]2[/SUB]:FiO[SUB]2[/SUB], norepinephrine doses, and lactate concentrations.
Results: The mean difference in days alive without life support was 5.7 days (95% credible interval (CrI): 0.2 to 11.2), with a 95.2% probability of clinically relevant benefit and a 98.0% probability of any benefit from the lower PaO[SUB]2[/SUB] target. The risk difference in 90-day mortality was -4.6 percentage points (95% CrI: -11.8 to 2.6), with a 76.5% probability of a clinically relevant benefit from the lower target. HTE analyses revealed potential interaction with baseline norepinephrine dose and lactate concentrations for both outcomes.
Interpretation: In ICU patients with COVID-19 and hypoxemia, we found high probability for a clinically relevant benefit of targeting a PaO[SUB]2[/SUB] of 60 mmHg vs. 90 mmHg on number of days alive without life support.
Keywords: Bayesian Analysis; COVID-19; Hypoxia; Intensive Care Units; Oxygen Inhalation Therapy; Respiratory Insufficiency.
. 2024 Sep 18:S0012-3692(24)05164-X.
doi: 10.1016/j.chest.2024.08.055. Online ahead of print. Lower or Higher Oxygenation Targets in ICU patients with COVID-19 - A secondary Bayesian analysis of the HOT-COVID trial
Frederik M Nielsen[SUP] 1 [/SUP], Thomas L Klitgaard[SUP] 2 [/SUP], Anders Granholm[SUP] 3 [/SUP], Theis Lange[SUP] 4 [/SUP], Anders Perner[SUP] 5 [/SUP], Olav L Schjørring[SUP] 2 [/SUP], Bodil S Rasmussen[SUP] 2 [/SUP]
Affiliations
- PMID: 39303806
- DOI: 10.1016/j.chest.2024.08.055
Background: In the Handling Oxygenation Targets in COVID-19 (HOT-COVID) trial, a partial pressure of arterial oxygen (PaO[SUB]2[/SUB]) target of 60 mmHg compared to 90 mmHg resulted in more days alive without life support at 90 days in adult ICU patients with coronavirus disease 2019 (COVID-19) and hypoxemia. The trial was stopped after enrolling 726 of 780 planned patients due to slow recruitment. Here, we present the preplanned Bayesian analysis of the HOT-COVID trial.
Research question: What are the probabilities of any and of clinically relevant benefits from a PaO[SUB]2[/SUB] target of 60 mmHg versus 90 mmHg in adult ICU patients with COVID-19 and hypoxemia, and is there heterogeneity of treatment effects (HTE) according to selected baseline characteristics?
Study design: and Methods We analyzed days alive without life support and 90-day mortality in the HOT-COVID intention-to-treat population (n=697) using Bayesian general linear models to assess probabilities for benefit or harm, including clinically relevant benefits defined as >1 day alive without life support and >2 percentage points lower 90-day mortality. HTE was evaluated based on baseline SOFA scores, PaO[SUB]2[/SUB]:FiO[SUB]2[/SUB], norepinephrine doses, and lactate concentrations.
Results: The mean difference in days alive without life support was 5.7 days (95% credible interval (CrI): 0.2 to 11.2), with a 95.2% probability of clinically relevant benefit and a 98.0% probability of any benefit from the lower PaO[SUB]2[/SUB] target. The risk difference in 90-day mortality was -4.6 percentage points (95% CrI: -11.8 to 2.6), with a 76.5% probability of a clinically relevant benefit from the lower target. HTE analyses revealed potential interaction with baseline norepinephrine dose and lactate concentrations for both outcomes.
Interpretation: In ICU patients with COVID-19 and hypoxemia, we found high probability for a clinically relevant benefit of targeting a PaO[SUB]2[/SUB] of 60 mmHg vs. 90 mmHg on number of days alive without life support.
Keywords: Bayesian Analysis; COVID-19; Hypoxia; Intensive Care Units; Oxygen Inhalation Therapy; Respiratory Insufficiency.