Trial reportIntensive care medicine2024
Fludrocortisone dose-response relationship in septic shock: a randomised phase II trial.
Trial report in Intensive care medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- [S3 guideline on sepsis-prevention, diagnosis, therapy, and follow-up care-update 2025].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2025Guideline
- Corticosteroids for sepsis and septic shock: a meta-analysis of 18 RCTs with dose-stratified and fludrocortisone subgroup evaluation.BMC anesthesiology · 2025Pooled it
- Corticosteroids for treating sepsis in children and adults.The Cochrane database of systematic reviews · 2025Pooled it
- Mineralocorticoid magic? Evaluating fludrocortisone in septic shock.British journal of clinical pharmacology · 2026Review
- A clinician's guide to corticosteroid therapy in pneumonia and critical illness: agent selection, dosing, monitoring, and interactions.Pneumonia (Nathan Qld.) · 2026Review
- Use of corticosteroids in sepsis and infectious diseases: a narrative review.The Korean journal of internal medicine · 2026Review
- Refractory septic shock: our updated pragmatic approach.Journal of anesthesia, analgesia and critical care · 2026Review
- Corticosteroids in sepsis.Journal of intensive medicine · 2025Review
- Honouring Rinaldo Bellomo's tour de force in sepsis research.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2025Review
- Current corticosteroid therapeutic strategy for community-acquired pneumonia in adults: indications, dosage, and timing.Journal of intensive care · 2025Review
- The Role of SR-BI in sepsis: leveraging mechanistic insights to advance precision steroid therapy.Frontiers in immunology · 2025Review
- Is fludrocortisone the missing piece in septic shock? A closer look.Intensive care medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors.
Funding
Abstract
backgroundThe combination of intravenous hydrocortisone and enteral fludrocortisone may reduce mortality in patients with septic shock. The optimal dose and reliability of absorption of fludrocortisone in critically ill patients are unclear.
methodsIn a multi-centre, open label, phase II randomized clinical trial, intravenous hydrocortisone alone or in combination with one of three doses of enteral fludrocortisone (50 µg, 100 µg or 200 µg daily) for 7 days was compared in patients with septic shock. The primary outcome was time to shock resolution. We conducted pharmacokinetic studies to assess absorption.
resultsOut of 153 enrolled patients, 38 (25%) received hydrocortisone alone, 42 (27%) received additional 50 µg, 36 (24%) received 100 µg and 37 (24%) received 200 µg fludrocortisone. Plasma concentrations of fludrocortisone were detected in 97% of patients at 3 h-median (interquartile range [IQR]) 261 (156-334) ng/L. There was no significant difference in the time to shock resolution between groups with median (IQR) of 3 (2.5-4.5), 3 (2-4), 3 (2-6) and 3 (2-5.5) days in the hydrocortisone alone, 50 µg, 100 µg and 200 µg fludrocortisone groups, respectively. The corresponding 28-day mortality rates were 9/38 (24%), 7/42 (17%), 4/36 (11%) and 4/37 (11%), respectively. There were no significant differences between groups with respect to, recurrence of shock, indices of organ failure or other secondary outcomes.
conclusionsEnteral 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.