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NCT04494789: FluDReSS
Fludrocortisone Dose Response Relationship in Septic Shock - FluDReSS
Phase 2 trial testing Fludrocortisone Acetate in Critically Ill in 155 participants. Completed in 30 June 2023.
30 April 2023
Quick facts
| Lead sponsor | The George Institute |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 155 |
| Start date | 11 February 2021 |
| Primary completion | 30 April 2023 |
| Estimated completion | 30 June 2023 |
| Sites | 9 locations across Australia |
Drugs / interventions tested
- Fludrocortisone Acetate (FLUDROCORTISONE ACETATE) — full drug profile →
- Fludrocortisone Acetate (FLUDROCORTISONE ACETATE) — full drug profile →
- Fludrocortisone Acetate (FLUDROCORTISONE ACETATE) — full drug profile →
- Standard Therapy — full drug profile →
Conditions studied
- Critically Ill — all drugs for Critically Ill →
- Septic Shock — all drugs for Septic Shock →
Sponsor
The George Institute
Who can join
18 and older, any sex, with Critically Ill or Septic Shock. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine the most suitable dose of Fludrocortisone in reversal of sepsis and shock associated with sepsis in patients who are admitted to the ICU. The investigators will be looking to see whether patients receiving Fludrocortisone at different doses recover quicker and spend less time in hospital and in ICU, and to understand the reasons why this happens at certain doses. Sepsis is caused by toxic substances (toxins) from bacteria and other organism entering the bloodstream from a site of infection. In some people, the infection can progress to sepsis and septic shock where the functions of organs in the body are affected. Patients suffering from sepsis and septic shock are commonly managed in the intensive care unit (ICU) where they are prescribed antibiotics as standard therapy, as well as other therapies to support the functions of the body. Fludrocortisone is a steroid that has previously shown to be beneficial to help in shock in patients in ICU, but more information is required about the exact dose that is required to achieve this. This has been shown by previous research. However, the exact role of Fludrocortisone and the best dose has not been studied adequately to date as well as the ways in how it works within the body. The study aims to look tat the dose and the way it works.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Fludrocortisone dose-response relationship in septic shock: a randomised phase II trial.
Walsham J, Hammond N, Blumenthal A, Cohen J, et al · · 2024 · cited 11× · PMID 39235623 · DOI 10.1007/s00134-024-07616-z
Verify or expand the search:
- PubMed search for NCT04494789
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04494789 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The George Institute
- Last refreshed: 18 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04494789.
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