Study Design Summary: Multicenter, double-blind trial of 2658 patients with septic shock randomized to either hydrocortisone or placebo for 7 days, with primary outcome all cause mortality at 90 days.
Notes: Patients were fairly similar in their baseline characteristics, there was slightly more epinephrine used in the hydrocortisone group, more patients in the control group had pulmonary source infection where as more patients with skin/soft tissue infection were in the hydrocortisone group but overall percentages for sites in each group were relatively similar. Time to randomization was pretty much similar, more patients in the 18-24 hour range (the latest range) came from the placebo group, thus favoring any potential positive benefit in the hydrocortisone group.
The primary outcome of all cause mortality showed no difference between the two groups. There were many secondary outcomes, most were not different between groups however there were some. Intervention vs control: shorter time to resolution of shock in steroid group (3 vs 4 days p<0.001), median time to discharge from ICU (10 vs 12 days p<0.001), number of days alive and out of the ICU (58 vs 56 days p=0.047). Other statically significant differences were more blood transfusions in the control group and shorter time to initial removal of ventilation in the steroid group. The authors note that while the steroid group did have a shorter time to initial vent discontinuation, there was more reintubation and the overall number of days on the ventilator between groups did not differ. In regards to the listed positive secondary outcomes, a day earlier or shock resolution but no mortality benefit (including 28 day all cause mortality as one of the secondary outcomes) doesn’t;t seem significant. Early ICU discharge is interesting in the steroid group but no real conclusions can be drawn from this secondary outcome. The 2 day difference of days alive out of the ICU isn’t impressive when its 58 vs 56 days. There were more adverse events in the steroid group but some of these included leukocytosis and hyperglycemia, which are likely of small to no clinical significance. Overall the secondary outcomes point towards possible promising trends and 90 day/28 day all cause mortality is likely an appropriate end point here, which showed no difference between the groups.
Study Conclusion: Hydrocortisone does not lower 90 day all cause mortality in patients with septic shock.
Fusion Beat Bottom Line Impression: This study does not demonstrate a 90 day or 28 day mortality benefit of steroids in septic shock.
A Fusion Beat 