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Sound waves aimed at spleen may tame deadly inflammation in septic shock

NCT ID NCT06990295

Disease control Sponsor: First Affiliated Hospital of Wannan Medical College Source: ClinicalTrials.gov ↗

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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.
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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 Results may not be published yet.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)
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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

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

Summary

This study tests whether a non-invasive ultrasound device, aimed at the spleen, can safely reduce dangerous inflammation in people with septic shock. Septic shock is a life-threatening condition where the body's response to infection causes organ damage. Forty adults in the intensive care unit will either receive standard care alone or standard care plus twice-daily ultrasound treatments for five days. Researchers will measure changes in inflammatory markers and track recovery, organ function, and survival.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

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

Started

Jul 2025

Expected to finish

Dec 2026

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: * Age ≥ 18 years, regardless of sex * Diagnosed with septic shock according to Sepsis-3 criteria: Sequential Organ Failure Assessment (SOFA) score ≥ 2 and requiring vasopressor support to maintain a mean arterial pressure (MAP) ≥ 65 mmHg. * Admitted to the ICU within 24 hours of septic shock diagnosis * Expected to require intensive care for at least 72 hours * Informed consent obtained from the patient or legal representative Exclusion Criteria: * Known pregnancy or breastfeeding * Participation in another interventional clinical trial within 30 days * Known immunodeficiency or ongoing immunosuppressive therapy * Malignancy with life expectancy \< 6 months * Contraindications to focused ultrasound (e.g., splenic trauma, splenectomy, local skin infection) * Do-not-resuscitate (DNR) order or expected death within 24 hours * Any other condition deemed unsuitable for participation by the investigators

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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.

Critical care Focused ultrasound Inflammatory cytokines Septic shock Spleen neuromodulation

How to take part

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  1. The places running it

    1 site. 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

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Contacts and locations

Locations

  • The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)

    RECRUITING

    Wuhu, Anhui, 241001, China

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