Tiny molecules may hold key to septic shock immune failure

NCT ID NCT07597122

Knowledge-focused Sponsor: Insel Gruppe AG, University Hospital Bern Source: ClinicalTrials.gov ↗

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

Summary

This study looks at small molecules called miRNAs in the blood of patients with septic shock. The goal is to understand why some patients develop a weakened immune system after sepsis, which can lead to more infections and higher risk of death. Researchers will compare miRNA patterns between septic shock patients and other critically ill patients to find early markers of immune suppression. The study does not test a new treatment but aims to gather knowledge that could guide future therapies.

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Study facts

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

Participants

About 56 people

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

Started

Jun 2026

Expected to finish

Dec 2027

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.

Who is studied

Patients receiving treatment in the ICU department of the University Hospital Bern, CH.

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: Septic shock: * New onset (\<24h) of septic shock diagnosis according to Sepsis-3 definition * (suspected) infection * Vasopressors required to maintain mean arterial pressure ≥65mm Hg (despite adequate fluid resuscitation) * Serum lactate level \> 2mmol/L * Minimum age of 18 years * Expected length of stay \>48h * Written consent from an independent physician Critically ill: * Patients on mechanical ventilation (MV) in the ICU without an admission diagnosis of sepsis/septic shock according to Sepsis-3 definition * Minimum age of 18 years * Expected length of stay \>48h * Written consent from an independent physician Exclusion Criteria: * Age \< 18 years * Patients known not to speak German or French * Patients with known. 1. Pre-existing congenital or acquired severe immune deficiency (e.g. severe combined immunodeficiency, HIV infection, AIDS) or 2. current immunosuppressive therapy (immunosuppressive biologicals or active lymphocyte therapy e.g. endoxan, rituximab or corticosteroid use at a dose \> 10 mg/day equivalent of prednisone. However, acute corticosteroid treatment of a relative adrenal insufficiency using a maximum hydrocortisone dose of 200 mg/day is accepted.

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Conditions

The condition(s) this trial relates to.

Sepsis toxic shock syndrome

As listed by the trial registrant

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

Sepsis and septic shock Sepsis induced immunosuppression 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

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.

Tiny molecules may hold key to septic shock immune failure

What the study statuses mean