Impact of Oxygen Targets on Sepsis Outcome: A Randomized Controlled Trial

Background:

Sepsis is a clinical syndrome marked by a dysregulated host response to infection, impairing oxygen delivery and utilization and causing organ dysfunction. Hypoxemia, which can cause significant tissue and organ damage, commonly occurs in sepsis. Thus, oxygen therapy is essential in patients with sepsis. However, the optimal oxygenation target for these patients remains controversial.

Objective:

To evaluate the effects of different oxygenation targets on short- and medium-term outcomes in patients with sepsis.

Methods:

A prospective, single-center, randomized controlled trial was conducted. The primary outcome was 28-day mortality. Secondary outcomes included 90-day mortality and intergroup comparisons of mechanical ventilation and vasopressor use during hospitalization.

Results:

In total, 270 patients were randomly assigned to the conservative oxygenation, conventional oxygenation, and hyperoxygenation target groups ( n = 86, 93, and 91), of whom 35 (40.7%), 32 (34.4%), and 17 (18.7%) died by day 28, respectively. The 28-day mortality significantly differed between these groups ( P = 0.005). Pairwise comparison revealed a significant difference between the conservative oxygenation and hyperoxygenation target groups (χ² = 10.132, P = 0.001). Kaplan–Meier analysis showed significant differences in survival distributions among the groups (χ² = 10.340, P = 0.006). The 90-day mortality rates were 50.0%, 41.9%, and 36.3% in the conservative oxygenation, conventional oxygenation, and hyperoxygenation target groups, respectively, exhibiting no significant difference.

Conclusion:

Compared with conservative oxygen therapy, hyperoxygenation (PaO ₂ : 100–150 mmHg) reduced 28-day mortality in patients with sepsis. However, no significant differences were observed among oxygenation targets regarding 90-day outcomes.

Clinical trial registration: Chinese Clinical Trial Register (ChiCTR2200064957, 2022-10-24).