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Hyperoxia and Hypertonic Saline in Patients with Septic Shock (HYPERS2S)
Hyperoxia and Hypertonic Saline in Patients with Septic Shock (HYPERS2S)
Asfar P, Schortgen F, Boisramé-Helms J, et al. Lancet Respir Med. 2017; 5: 180-190.
Study Question: Is the use of hyperoxia compared to normoxia and hypertonic saline compared to isotonic saline safer and more effective in septic shock patients?
Study Description: A two-by-two factorial, multi-center, controlled trial was performed in patients treated with either open-label hyperoxia (FiO2 1.0) or normoxia (arterial hemoglobin oxygen saturation 88-95%) for 24 hours and double blind 3% hypertonic saline or 0.9% isotonic saline for 72 hours. Included patients were intubated, had septic shock refractory to fluids, and were assessed within 6 hours of vasopressor initiation. Exclusion criteria were severe hypoxemia, altered baseline plasma sodium concentrations, intracranial hypertension, or cardiac issues. The primary endpoint was 28 day mortality. Secondary endpoints included 90 day mortality, ICU length of stay, and serious adverse events.
Results: In June 2014, the trial was ended early due to excess risk and the absence of any benefit of both interventions. Of the 442 patients evaluated, 223 were in the normoxia group, 219 were in the hyperoxia group, 224 received isotonic saline, and 218 received hypertonic saline. Patients in the hyperoxia group had a numerically greater mortality rate (43% vs. 35%, p = 0.12), experienced more serious adverse events (85% vs. 76%, p = 0.02) and atelectasis (12% vs. 6%, p = 0.04), and a trend toward greater ICU-acquired weakness (11% vs. 6%, p = 0.06). Patients in the hypertonic group had a higher mortality rate (42% vs. 37%, p = 0.25), though no difference in serious adverse events. There were no significant differences in 90-day mortality or ICU length of stay in either group.
Conclusion(s): In patients with septic shock, hyperoxia and hypertonic saline as a resuscitative fluid did not reduce mortality. Inducing hyperoxia by setting FiO2 to 1.0 might increase mortality.
Perspective: Literature has shown that high arterial oxygen partial pressures are associated with increased risk of mortality. In addition, previous trials on resuscitation in trauma patients have shown that hypertonic saline does not improve outcomes. The findings of this trial are consistent with previous literature and further support against the use of hyperoxia or hypertonic saline during the initial management of septic shock.