Adjunctive Fludrocortisone in Septic Shock

NCT07451886 | Recruiting Phase 2 DMC

• 1 other identifier: 2024.398
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Sepsis and Septic Shock; Sepsis at Intensive Care Unit; Sepsis - to Reduce Mortality in the Intensive Care Unit; Sepsis; Septic Shock

Keywords

Fludrocortisone; Septic shock; Sepsis; hydrocortisone; intensive care unit; pilot

Outcome Measures

Primary Outcomes (4)

• Number of Protocol deviations < 15%

  Defined as \<15% of recruited subjects that had at least one protocol deviation during the duration of intervention

  End of study approximately 20 months

• Number of Lost of concealment < 10%

  Defined as \<10% of recruited subjects that lost blinding of allocations to either the patient, clinical or trial statistician

  End of study approximately 20 months

• Number of Drop out < 10%

  Defined as \<10% of recruited subjects who drop out of the study after recruitment

  End of study approximately 20 months

• Number of Missing data < 10%

  Defined as \<10% of data with missing values for each data category including lost to follow up

  End of study approximately 20 months

Secondary Outcomes (9)

• Number of Monthly Recruitment

  End of study approximately 20 months

• Time to resolution of shock

  Until patient discharge from ICU

• 28-day mortality

  First 28 days after enrollment

• Days alive and vasopressor-free until day 28

  First 28 days after enrollment

• Days alive and ventilator-free until day 28

  First 28 days after enrollment

Study Arms (2)

Fludrocortisone

EXPERIMENTAL

Drug: Fludrocortisone 100 mcg daily

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Fludrocortisone 100 mcg daily DRUG

Patients will be given enteral fludrocortisone 100 mcg daily for 7 days or until discharge from ICU or death, whichever comes first. All patients will be treated with 7 days of intravenous hydrocortisone 50 mg every 6 hours for 7 days from randomization or until discharge from ICU or death, whichever comes first.

Fludrocortisone

Placebo DRUG

Patients will be given an enteral placebo tablet for 7 days or until discharge from ICU or death, whichever comes first. All patients will be treated with 7 days of intravenous hydrocortisone 50 mg every 6 hours for 7 days from randomization or until discharge from ICU or death, whichever comes first.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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
• enteral medication cannot be administered
• prescribed fludrocortisone for other medical condition
• contraindication to hydrocortisone or fludrocortisone

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (5)

North District Hospital

Hong Kong, Hong Kong

NOT YET RECRUITING

Pamela Youde Nethersole Hospital

Hong Kong, Hong Kong

NOT YET RECRUITING

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Princess Margaret Hospital

Hong Kong, Hong Kong

NOT YET RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong

NOT YET RECRUITING

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Fludrocortisone

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Hydrocortisone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Lowell Ling, MBBS

CONTACT

(852) 35052735; lowell.ling@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Pilot, multicenter, randomized, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: March 5, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-02

Locations

HK (5)