Focused ultrasound spleen stimulation for septic shock in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized pilot study, adults with septic shock receive either standard care or standard care plus twice-daily, non-invasive focused ultrasound to the spleen for five days. The goal is to see if spleen neuromodulation lowers inflammatory cytokines and influences organ function. Researchers will measure cytokine levels (TNF-α, IL-1β, IL-6, IL-10), lymphocyte subpopulations, SOFA scores, ICU stay, and 28-day mortality, while monitoring safety. The study uses a portable device to deliver targeted energy to the splenic region in the intervention arm. Outcomes will help determine if this approach is a safe and potentially effective immunomodulatory therapy for septic shock.

Why it matters

Who can join: the full rules

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

Where it's running

• The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
  Wuhu, Anhui, China Recruiting

Study contacts

• Study coordinator: Qiancheng Xu
• Email: qianchengxu@wnmc.edu.cn
• Phone: 86-18297529106

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.