Focused Ultrasound Spleen Stimulation and Inflammation in Septic Shock

Recruiting now · Not applicable

Conditions studied: Septic Shock, Inflammatory Cytokines, Spleen Neuromodulation, Focused Ultrasound, Critical Care

In brief

This study evaluates the safety and effectiveness of focused ultrasound spleen neuromodulation in patients with septic shock, a life-threatening condition characterized by excessive inflammation and organ dysfunction. The primary objective is to determine whether non-invasive, focused ultrasound stimulation of the spleen can reduce circulating inflammatory cytokine levels in this patient population. Eligibility Criteria: Adults aged 18 years or older Diagnosed with septic shock and admitted to the ICU within 24 hours Expected to require intensive care for at least 72 hours Study Protocol: Participants will be randomly assigned to one of two groups: Intervention Group: Will receive standard septic shock care plus twice-daily focused ultrasound stimulation over the spleen for five days, using a portable device. Control Group: Will receive standard septic shock care alone. Blood samples will be collected at baseline and Day 5 to measure inflammatory cytokine levels, including TNF-α, IL-1β, IL-6, and IL-10. Additional assessments will include lymphocyte subpopulations, organ function scores, ICU length of stay, 28-day mortality, and adverse events. Outcome Measures: Primary: Change in levels of inflammatory cytokines on Day 5. Secondary: Changes in organ function (SOFA score), ICU length of stay, 28-day survival, and safety/tolerability of the intervention.

Key facts

Study ID

NCT06990295

Run by

First Affiliated Hospital of Wannan Medical College

People needed

40

Starts

2025-07-25

Expected to finish

2026-12-31

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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