Could two steroids slash septic shock deaths?

NCT ID NCT07383103

Disease control Sponsor: Northern Jiangsu People's Hospital Source: ClinicalTrials.gov ↗

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

Summary

This study tests whether giving two steroids—hydrocortisone and fludrocortisone—for up to 7 days can lower the risk of death in adults with septic shock. About 336 patients will be randomly assigned to receive either the steroid combo or standard care alone. The main goal is to see if the treatment reduces deaths within 90 days.

What this could mean

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

Active substance: Hydrocortisone and fludrocortisone (steroid drugs)
What this could lead to: If it works, this could offer a simple, short-term drug combo to lower death rates in septic shock patients.
What could go wrong: This is a phase 4 trial, so the drugs are already approved, but septic shock is complex and previous steroid studies have had mixed results. Side effects like infections or gastrointestinal issues are possible.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 336 people

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

Started

Mar 2026

Expected to finish

Dec 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 to 90 years

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)18≤Age≤90; (2)Diagnosis of septic shock within 12 h. Exclusion Criteria: Patients meeting any of the following conditions will be excluded: 1. Systemic corticosteroid therapy within the last 3 months before septic shock; 2. High-dose steroid therapy; 3. Immunosuppression; 4. Pregnant; 5. Known allergy to hydrocortisone or fludrocortisone; 6. Presence of gastrointestinal bleeding, perforation, or other conditions requiring fasting; 7. Anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician); 8. Refusal of the attending staff or patient family; 9. Current participation in another clinical trial.

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Conditions

The condition(s) this trial relates to.

toxic shock syndrome

As listed by the trial registrant

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

Septic shock

How to take part

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

The places running it

1 site. The list below names each one and where it is.
The official record

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

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A doctor treating you

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Could two steroids slash septic shock deaths?

What the study statuses mean