Status:
COMPLETED
Fludrocortisone Dose Response Relationship in Septic Shock - FluDReSS
Lead Sponsor:
The George Institute
Conditions:
Critically Ill
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 w...
Detailed Description
Aim: 1. To conduct a multi-centre randomised controlled trial to assess the effect of 3 different dose regimens of fludrocortisone on shock reversal in septic shock patients treated with hydrocortiso...
Eligibility Criteria
Inclusion
- Aged 18 years or older
- Documented site, or strong suspicion of infection with 2 of the 4 clinical signs of inflammation:
- Core temperature \> 38oC or \< 35oC
- Heart rate \> 90bpm
- Respiratory rate \> 20bpm, or PaCO2 \< 32mmHg, or mechanical ventilation
- White cell count \> 12 x 109/L or \< 4 x 109/L or \> 10% immature neutrophils\\
- Being treated with Hydrocortisone at a daily dose of 200mg / day as adjunctive treatment for sepsis
- Being treated with mechanical ventilation at the time of randomisation (includes mask BiPAP/CPAP)
- 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
- Administration of vasopressors or inotropes for \> 4 hours and present at time of randomisation
Exclusion
- Met all inclusion criteria more than 24 hours ago
- Patients taking long term corticosteroids or fludrocortisone
- Patients with systemic fungal infection
- 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
- Patient unable to receive enteral medication
- Death from underlying disease likely within 90 days
- Patient has been previously enrolled in the study
Key Trial Info
Start Date :
February 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT04494789
Start Date
February 11 2021
End Date
June 30 2023
Last Update
January 18 2024
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Blacktown Hospital
Sydney, New South Wales, Australia
2
Royal North Shore Hospital
Sydney, New South Wales, Australia
3
Royal Brisbane Women's Hospital
Brisbane, Queensland, Australia
4
Wesley Hospital
Brisbane, Queensland, Australia