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HOT-ICU

Trial question
Is lower oxygenation target superior to higher oxygenation target in patients with acute hypoxemic respiratory failure?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 2910
2910 patients (1039 female, 1871 male).
Inclusion criteria: adult patients with acute hypoxemic respiratory failure in the ICU.
Key exclusion criteria: not randomized within 12 hours of ICU admission; receives chronic mechanical ventilation; use of home oxygenation; previous treatment with bleomycin; pregnancy.
Interventions
N=1453 lower oxygenation target (partial pressure of oxygen in arterial blood 60 mmHg).
N=1457 higher oxygenation target (partial pressure of oxygen in arterial blood 90 mmHg).
Primary outcome
Death at day 90
42.9%
42.4%
42.9 %
32.2 %
21.4 %
10.7 %
0.0 %
Lower oxygenation target
Higher oxygenation target
No significant difference ↔
No significant difference in death at day 90 (42.9% vs. 42.4%; RR 1.02, 95% CI 0.94 to 1.11).
Secondary outcomes
No significant difference in the rate of days that patients were alive without life support (87.8% vs. 84.4%; AD 3.4%, 95% CI -0.65 to 7.45).
No significant difference in the rate of days that patients were alive after hospital discharge (55.6% vs. 50%; AD 5.6%, 95% CI -19.12 to 30.32).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult patients with acute hypoxemic respiratory failure in the ICU, lower oxygenation target was not superior to higher oxygenation target with respect to death at day 90.
Reference
Olav L Schjørring, Thomas L Klitgaard, Anders Perner et al. Lower or Higher Oxygenation Targets for Acute Hypoxemic Respiratory Failure. N Engl J Med. 2021 Apr 8;384(14):1301-1311.
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