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Could a second steroid boost survival in septic shock? tiny trial paves way

NCT ID NCT07451886

Disease control Sponsor: Chinese University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether adding fludrocortisone (a steroid pill) to standard hydrocortisone treatment helps people with septic shock. Only 32 critically ill adults will take part. The main goal is not to see if the combo works, but to check if a larger, more definitive trial is possible.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fludrocortisone (a steroid hormone) given as a pill, plus standard hydrocortisone (another steroid) given intravenously
What this could lead to
If this pilot shows the larger trial is feasible, it could lead to a definitive study that may prove adding fludrocortisone saves more lives from septic shock.
What could go wrong
This is a very small pilot (32 patients) testing only whether a larger trial can be done, not whether the drug works. Even if the larger trial happens, the combination may not reduce deaths.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. suspected or confirmed adult sepsis as defined by ≥ 2 increase in Sequential Organ Failure Assessment (SOFA) score due to infection 2. ≥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 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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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis Sepsis toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sepsis Sepsis - to reduce mortality in the intensive care unit Sepsis and septic shock Sepsis at intensive care unit Septic shock

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • North District Hospital

    NOT_YET_RECRUITING

    Hong Kong, Hong Kong

  • Pamela Youde Nethersole Hospital

    NOT_YET_RECRUITING

    Hong Kong, Hong Kong

  • Prince of Wales Hospital

    RECRUITING

    Hong Kong, Hong Kong

  • Princess Margaret Hospital

    NOT_YET_RECRUITING

    Hong Kong, Hong Kong

  • Queen Mary Hospital

    NOT_YET_RECRUITING

    Hong Kong, Hong Kong

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