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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04494789




Registration number
NCT04494789
Ethics application status
Date submitted
19/07/2020
Date registered
31/07/2020
Date last updated
18/01/2024

Titles & IDs
Public title
Fludrocortisone Dose Response Relationship in Septic Shock - FluDReSS
Scientific title
A Phase II Open Label Randomised Controlled Clinical Trial of Different Dosing Regimens of Fludrocortisone in Septic Shock With Assessment of Temporal Changes in Hormonal, Inflammatory, and Genetic Markers of Vascular Responsiveness
Secondary ID [1] 0 0
GI-CC35837377
Universal Trial Number (UTN)
Trial acronym
FluDReSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically Ill 0 0
Septic Shock 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fludrocortisone Acetate
Treatment: Drugs - Fludrocortisone Acetate
Treatment: Drugs - Fludrocortisone Acetate
Other interventions - Standard Therapy

Active comparator: Fludrocortisone dosing regime: 24hrs - Receive 50mcg doses of fludrocortisone every 24hrs

Active comparator: Fludrocortisone dosing regime: 12hrs - Receive 50mcg doses of fludrocortisone every 12hrs

Active comparator: Fludrocortisone dosing regime: 6hrs - Receive 50mcg doses of fludrocortisone every 6hrs

Placebo comparator: Control Arm - Receives standard treatment without fludrocortisone dosing regime


Treatment: Drugs: Fludrocortisone Acetate
50mcg

Treatment: Drugs: Fludrocortisone Acetate
100mcg

Treatment: Drugs: Fludrocortisone Acetate
200mcg

Other interventions: Standard Therapy
NO Fludrocortisone
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to resolution of shock by Intervention group allocation
Timepoint [1] 0 0
7 DAYS
Primary outcome [2] 0 0
Time to resolution of shock and Fludrocortisone Levels
Timepoint [2] 0 0
7 days
Primary outcome [3] 0 0
Vasopressor Responsiveness by Intervention group allocation
Timepoint [3] 0 0
7 days
Primary outcome [4] 0 0
Vasopressor Responsiveness and Fludrocortisone Levels
Timepoint [4] 0 0
7 days
Secondary outcome [1] 0 0
Recurrence of shock
Timepoint [1] 0 0
censored at day 28
Secondary outcome [2] 0 0
Ventilation free days
Timepoint [2] 0 0
censored at day 28
Secondary outcome [3] 0 0
ICU and hospital length of Stay
Timepoint [3] 0 0
censored at day 28
Secondary outcome [4] 0 0
ICU and hospital mortality
Timepoint [4] 0 0
censored at day 28
Secondary outcome [5] 0 0
Delta SOFA Score
Timepoint [5] 0 0
censored at day 28
Secondary outcome [6] 0 0
Maximal SOFA score
Timepoint [6] 0 0
censored at day 28
Secondary outcome [7] 0 0
Superinfection
Timepoint [7] 0 0
censored at day 28

Eligibility
Key inclusion criteria
1. Aged 18 years or older
2. Documented site, or strong suspicion of infection with 2 of the 4 clinical signs of inflammation:

1. Core temperature > 38oC or < 35oC
2. Heart rate > 90bpm
3. Respiratory rate > 20bpm, or PaCO2 < 32mmHg, or mechanical ventilation
4. White cell count > 12 x 109/L or < 4 x 109/L or > 10% immature neutrophils
3. Being treated with Hydrocortisone at a daily dose of 200mg / day as adjunctive treatment for sepsis
4. Being treated with mechanical ventilation at the time of randomisation (includes mask BiPAP/CPAP)
5. Being treated with continuous vasopressors or inotropes to maintain a systolic blood pressure > 90mmHg, or mean arterial pressure > 60mmHg or a MAP target set by the treating clinician for maintaining perfusion
6. Administration of vasopressors or inotropes for > 4 hours and present at time of randomisation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Met all inclusion criteria more than 24 hours ago
2. Patients taking long term corticosteroids or fludrocortisone
3. Patients with systemic fungal infection
4. Death is deemed inevitable or imminent during this admission and either the attending physician, patient or surrogate legal decision maker is not committed to active treatment
5. Patient unable to receive enteral medication
6. Death from underlying disease likely within 90 days
7. Patient has been previously enrolled in the study

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2023
Sample size
Target
Accrual to date
Final
155
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Blacktown Hospital - Sydney
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [3] 0 0
Royal Brisbane Women's Hospital - Brisbane
Recruitment hospital [4] 0 0
Wesley Hospital - Brisbane
Recruitment hospital [5] 0 0
Gold Coast University Hospital - Gold Coast
Recruitment hospital [6] 0 0
Mater Misericordiae - Raymond Terrace
Recruitment hospital [7] 0 0
Princess Alexandra Hospiital - Woolloongabba
Recruitment hospital [8] 0 0
Queen Elizabeth II Hospital - Adelaide
Recruitment hospital [9] 0 0
Austin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Gold Coast
Recruitment postcode(s) [4] 0 0
4101 - Raymond Terrace
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
- Adelaide
Recruitment postcode(s) [7] 0 0
- Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04494789
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Walsham, MB ChB, MRCP, FCICM.
Address 0 0
Princess Alexandra Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04494789