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Adjunctive Fludrocortisone in Septic Shock

RecruitingPhase 2Ages 18 Years - anyAllChinese University of Hong Kong
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In plain words

What the trial is, and whether it could suit you

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. Recent analyses suggest that combining fludrocortisone with hydrocortisone may be more effective at saving lives than hydrocortisone alone. To test this hypothesis, a large, definitive international trial is needed. However, this research proposal is for a smaller pilot study (Phase II) involving 32 critically ill patients. The primary goal of this pilot is to determine the feasibility of conducting the subsequent large-scale trial that would compare hydrocortisone alone against the combination therapy and potentially change medical practice.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. suspected or confirmed adult sepsis as defined by โ‰ฅ 2 increase in Sequential Organ Failure Assessment (SOFA) score due to infection 2. โ‰ฅ0.25 ฮผg/kg/min of noradrenaline infusion or vasoactive-inotropic score (VIS) โ‰ฅ25 to maintain mean arterial pressure (MAP) โ‰ฅ65 mmHg for at least 1 hour 3. onset of septic shock within 24 hours 4. shock due to infection with no other proven or apparent cause 5. hypoperfusion defined as arterial or venous lactate concentration \>2.0 mmol/L 6. mechanical ventilation Exclusion Criteria: 1. fludrocortisone cannot be administered within 24 hours of onset of septic shock 2. death is deemed imminent or inevitable by treating clinicians 3. limitation of therapy 4. an underlying disease process with a life expectancy of less than 90 days 5. pregnancy (confirmed or suspected) 6. receiving immunomodulatory agents including hydrocortisone \> 300mg/day 7. enteral medication cannot be administered 8. prescribed fludrocortisone for other medical condition 9. contraindication to hydrocortisone or fludrocortisone
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What it tests

  • Fludrocortisone 100 mcg daily
  • Placebo
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Where

5 sites
North District Hospital
Hong Kong, Hong Kong
Pamela Youde Nethersole Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Princess Margaret Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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