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New treatment option for Sepsis
Official title Adjunctive Fludrocortisone in Septic Shock
ClinicalTrials.gov ID: NCT07451886
What this study is testing
What is Fludrocortisone 100 mcg daily?
Fludrocortisone 100 mcg daily is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for sepsis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Sepsis is a life-threatening condition caused by the body's dysregulated response to an infection. While corticosteroids are known to help stabilize blood pressure in septic shock, their ability to reduce mortality is still debated.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- suspected or confirmed adult sepsis as defined by ≥ 2 increase in Sequential Organ Failure Assessment (SOFA) score due to infection
- ≥0.25 μg/kg/min of noradrenaline infusion or vasoactive-inotropic score (VIS) ≥25 to maintain mean arterial pressure (MAP) ≥65 mmHg for at least 1...
- onset of septic shock within 24 hours
- shock due to infection with no other proven or apparent cause
- hypoperfusion defined as arterial or venous lactate concentration \>2.0 mmol/L
You likely can't join if
- fludrocortisone cannot be administered within 24 hours of onset of septic shock
- death is deemed imminent or inevitable by treating clinicians
- limitation of therapy
- an underlying disease process with a life expectancy of less than 90 days
- pregnancy (confirmed or suspected)
- receiving immunomodulatory agents including hydrocortisone \> 300mg/day
See the full eligibility criteria
- suspected or confirmed adult sepsis as defined by ≥ 2 increase in Sequential Organ Failure Assessment (SOFA) score due to infection
- ≥0.25 μg/kg/min of noradrenaline infusion or vasoactive-inotropic score (VIS) ≥25 to maintain mean arterial pressure (MAP) ≥65 mmHg for at least 1 hour
- onset of septic shock within 24 hours
- shock due to infection with no other proven or apparent cause
- hypoperfusion defined as arterial or venous lactate concentration \>2.0 mmol/L
- mechanical ventilation
- fludrocortisone cannot be administered within 24 hours of onset of septic shock
- death is deemed imminent or inevitable by treating clinicians
- limitation of therapy
- an underlying disease process with a life expectancy of less than 90 days
- pregnancy (confirmed or suspected)
- receiving immunomodulatory agents including hydrocortisone \> 300mg/day
- enteral medication cannot be administered
- prescribed fludrocortisone for other medical condition
- contraindication to hydrocortisone or fludrocortisone
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.