Hydrocortisone plus fludrocortisone for community acquired pneumonia-related septic shock: a subgroup analysis of the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) phase 3 randomised trial
Authors' conclusion
In a pre-specified subgroup analysis of the APROCCHSS trial of patients with CAP and septic shock, hydrocortisone plus fludrocortisone reduced mortality as compared with placebo.
Study context
- Population
- Adults with septic shock, with or without community acquired pneumonia (CAP), 34 centres in France562 CAP, 648 non-CAP
- Participants
- 1,241 adults
- Comparison
- Hydrocortisone plus fludrocortisone vs placebo, in CAP vs non-CAP septic shock
- Primary endpoint
- All-cause mortality
- Follow-up
- 90 days
Methodological detailsa priori planned exploratory subgroup analysis, double-blind, placebo-controlled, two-by-two factorial, multicentre, CAP could not be ruled in or out in 31 patients
- A priori planned exploratory subgroup analysis
- Double-blind
- Placebo-controlled
- Two-by-two factorial
- Multicentre
- CAP could not be ruled in or out in 31 patients
Primary result
As reported in the abstract
90-day all-cause mortality, CAP and non-CAP subgroups · day 90
Each group vs placeboOdds ratio (95% CI)
Hydrocortisone plus fludrocortisonepatients with CAP
0.60(0.43–0.83)
Hydrocortisone and fludrocortisonepatients without CAP
0.95(0.70–1.29)
Secondary outcomes
90-day mortality, ARDS subgroup
Subgroup Corticosteroid ARDS; n = 320 · Placebo ARDS; n = 328
- 90-day mortality, ARDS subgroup — OR for death at day 90, patients with ARDS
- 0.72 (95% CI 0.53-0.98)
- 90-day mortality, ARDS subgroup — OR for death at day 90, patients without ARDS
- 0.85 (0.61-1.20)
- 90-day mortality, ARDS subgroup: p=0.45 for multiplicative interaction and p=0.42 for additive interaction
Safety
| Outcome | OR (95% CI) | |
|---|---|---|
| At least one serious adverse event · within 180 daysCorticosteroid (CAP) vs Placebo (CAP) | 0.64 (0.46–0.89) | |
| At least one serious adverse event · within 180 daysCorticosteroid (non-CAP) vs Placebo (non-CAP) | 1.02 (0.75–1.39) | |
| 0.512Odds ratio (log scale) |
- At least one serious adverse event: p=0.044 for multiplicative interaction and p=0.042 for additive interaction
Original publication
Hydrocortisone plus fludrocortisone for community acquired pneumonia-related septic shock: a subgroup analysis of the APROCCHSS phase 3 randomised trial. Lancet Respir Med. Published 1 February 2024. doi:10.
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