MedTrace Logo

Adjunctive Fludrocortisone in Septic Shock

NCT07451886 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-03-05

No results posted yet for this study

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

Interventions

DRUG

Fludrocortisone 100 mcg daily

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07451886 on ClinicalTrials.gov