Focused Ultrasound Spleen Stimulation and Inflammation in Septic Shock

Condition(s) studied

Investigational drug(s) / intervention(s)

Focused Ultrasound Spleen Neuromodulation: A portable focused ultrasound device is used to stimulate the spleen area under real-time imaging guidance. Each session lasts approximately 20 minutes, repeated twice daily for five days.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Inflammatory Cytokine Levels — Baseline and Day 5
  Change in plasma levels of key inflammatory cytokines (e.g., TNF-α, IL-1β, IL-6, IL-10) from baseline to Day 5 after randomization.

Trial sites (1)

More First Affiliated Hospital of Wannan Medical College trials in China

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