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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07898462




Registration number
Help: Registration number
NCT07898462
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
14/07/2026
Date registered
Help: Date registered
27/10/2026
Date last updated
Help: Date last updated
30/10/2026

Titles & IDs
Public title
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Scientific title
Adjunctive FLUDrocortisone With tRanscriptOme Evaluation in Septic SHOCK (FLUDRO-SHOCK)
Additional trial identifiers [1] 0 0
ACTRN12626000627358
Additional trial identifiers [2] 0 0
TGI 358376-74625
Universal Trial Number (UTN)
Trial acronym
FLUDRO-SHOCK
Related trial records

Health condition
Health condition(s) studied:
Septic Shock 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - Fludrocortisone 50 mcg daily
Treatment: Drugs - Fludrocortisone 100 mcg daily
Treatment: Drugs - Placebo

Active comparator: Fludrocortisone 50 mcg daily - The intervention will be fludrocortisone acetate 50 mcg daily, administered orally or via an in situ gastric tube for 7 days or until discharge from ICU, whichever is sooner.

Active comparator: Fludrocortisone 100 mcg daily - The intervention will be fludrocortisone acetate 100 mcg daily, administered orally or via an in situ gastric tube for 7 days or until discharge from ICU, whichever is sooner.

Placebo comparator: Placebo - Matching placebo tablet dosed daily, administered orally or via an in situ gastric tube for 7 days or until discharge from ICU, whichever is sooner.


Treatment: Drugs: Fludrocortisone 50 mcg daily
The intervention will be fludrocortisone acetate 50 mcg daily, administered orally or via an in situ gastric tube for 7 days or until discharge from ICU, whichever is sooner.

Treatment: Drugs: Fludrocortisone 100 mcg daily
The intervention will be fludrocortisone acetate 100 mcg daily, administered orally or via an in situ gastric tube for 7 days or until discharge from ICU, whichever is sooner.

Treatment: Drugs: Placebo
The intervention will be placebo tablet administered orally or via an in situ gastric tube for 7 days or until discharge from ICU, whichever is sooner.
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Days alive and free of organ support to day 28
Timepoint [1] 0 0
From randomisation through day 28 after randomisation.
Secondary outcome [1] 0 0
All-cause mortality
Timepoint [1] 0 0
28 days, 90 days, 6 months and 12 months after randomisation
Secondary outcome [2] 0 0
Days alive and free of organ support to day 90
Timepoint [2] 0 0
From randomisation through day 90 after randomisation.
Secondary outcome [3] 0 0
Proportion of patients treated with new-onset renal replacement therapy
Timepoint [3] 0 0
From randomisation through day 90 after randomisation.
Secondary outcome [4] 0 0
Days alive and free of invasive mechanical ventilation through day 90
Timepoint [4] 0 0
From randomisation through day 90 after randomisation
Secondary outcome [5] 0 0
Days alive and outside the intensive care unit through day 90
Timepoint [5] 0 0
From randomisation through day 90 after randomisation
Secondary outcome [6] 0 0
Days alive outside hospital through day 90
Timepoint [6] 0 0
From randomisation through day 90 after randomisation
Secondary outcome [7] 0 0
Number of hospital readmissions through day 90
Timepoint [7] 0 0
90 days after randomisation
Secondary outcome [8] 0 0
Number of new-onset infections during the index hospital admission
Timepoint [8] 0 0
From 2 days after randomisation until discharge from the index hospital admission.
Secondary outcome [9] 0 0
Functional status assessed using the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Timepoint [9] 0 0
90 days, 6 months and 12 months after randomisation.
Secondary outcome [10] 0 0
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) index score
Timepoint [10] 0 0
90 days, 6 months and 12 months after randomisation.
Secondary outcome [11] 0 0
Health-related quality of life assessed using the EuroQol Visual Analogue Scale (EQ-VAS) index score
Timepoint [11] 0 0
90 days, 6 months and 12 months after randomisation.

Eligibility
Key inclusion criteria
1. Shock presumed due to infection
2. Treatment with vasopressors to maintain a Systolic Blood Pressure (SBP) >90mmHg or Mean Arterial Pressure (MAP) > 65mmHg, after having received adequate fluid resuscitation (in the opinion of the treating clinician)
3. Plasma lactate concentration >2mmol/L
4. Being treated with hydrocortisone 200mg/day as adjunctive treatment for septic shock
5. Being treated with one of the following:

1. Invasive Mechanical Ventilation OR
2. Non-invasive ventilation (CPAP or BiPAP) OR
3. Oxygen supplementation with an oxygen flow of >10L/min independent of delivery system and an FiO2 of 0.5 or above., OR
4. Use of Veno-venous ECMO
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Met all inclusion criteria for more than 12 hours
2. Death is deemed imminent or inevitable by treating ICU specialist
3. Patients with documented systemic fungal infection at the time of randomisation
4. Patients with documented allergy to fludrocortisone
5. Patients unable to receive enteral medications
6. An underlying disease process with a life expectancy of less than 28 days
7. Pregnancy (confirmed or suspected)
8. Receiving hydrocortisone (HC) or fludrocortisone (FC) for conditions other than septic shock
9. Prior enrolment in this trial
10. Known or documented objections to research participation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
16/10/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2031
Actual
Sample size
Target
2200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Nepean Hospital - Penrith
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [3] 0 0
Royal Brisbane and Women's hospital - Brisbane
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [5] 0 0
Caboolture Hospital - Caboolture
Recruitment hospital [6] 0 0
Gold Coast University Hospital - Gold Coast
Recruitment hospital [7] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [8] 0 0
Austin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2751 - Penrith
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
4006 - Brisbane
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
4510 - Caboolture
Recruitment postcode(s) [6] 0 0
4215 - Gold Coast
Recruitment postcode(s) [7] 0 0
- Adelaide
Recruitment postcode(s) [8] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Professor Balasubramanian (Bala) Venkatesh
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Senior Project Manager
Address 0 0
Country 0 0
Phone 0 0
+61 2 8052 4460
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07898462