Fludrocortisone dose–response relationship in septic shock: a randomised phase II trial
Authors' conclusion
Enteral fludrocortisone resulted in detectable plasma fludrocortisone concentrations in the majority of critically ill patients with septic shock, although they varied widely indicating differing absorption and bioavailability. Its addition to hydrocortisone was not associated with shorter time to shock resolution.
Study context
- Population
- Patients with septic shockenrolled
- Participants
- 153 patients
- Comparison
- Hydrocortisone alone vs hydrocortisone plus enteral fludrocortisone 50, 100 or 200 µg daily for 7 days
- Hydrocortisone alonen = 38reference
- 50 µgn = 42
- 100 µgn = 36
- 200 µgn = 37
- Primary endpoint
- Time to shock resolution
Methodological detailsmulticentre, open label, phase II
- Multicentre
- Open label
- Phase II
Primary result
As reported in the abstract
Secondary outcomes
- 28-day mortality · 28 days — Hydrocortisone alone
- 24%
Plasma fludrocortisone concentration (absorption) · 3 h
- Plasma fludrocortisone detected (% of patients)
- 97%
- Plasma fludrocortisone concentration, median (IQR), ng/L
- 261 (156-334)
Recurrence of shock, organ failure indices, other secondary outcomes
- No significant differences between groups
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Fludrocortisone dose–response relationship in septic shock: a randomised phase II trial. Intensive Care Med. Published 5 September 2024. doi:10.
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