Focused Ultrasound Spleen Stimulation and Inflammation in Septic Shock

First Affiliated Hospital of Wannan Medical College

Status: Not yet enrolling

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

Treatments: Procedure: Focused Ultrasound Spleen Neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06990295

202580

Details and patient eligibility

About

This study evaluates the safety and effectiveness of focused ultrasound spleen neuromodulation in patients with septic shock, a life-threatening condition marked by excessive inflammation and organ dysfunction. The primary aim is to determine whether non-invasive, focused ultrasound stimulation of the spleen can reduce levels of circulating inflammatory cytokines in this 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, Day 3, and Day 5 to measure inflammatory cytokine levels, such as TNF-α, IL-1β, IL-6, and IL-10. Additional assessments include lymphocyte subpopulations, organ function scores, ICU length of stay, 28-day mortality, and recording of any adverse events.

Outcome Measures Primary: Change in levels of inflammatory cytokines on Day 3 and Day 5 Secondary: Changes in organ function (SOFA score), ICU length of stay, 28-day survival, and safety/tolerability of the intervention Significance Focused ultrasound spleen neuromodulation is a novel, non-invasive procedure that may activate the body's anti-inflammatory pathways. This pilot study will provide preliminary evidence on its potential to regulate inflammation and improve outcomes in patients with septic shock, informing future research and clinical practice.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Focused Ultrasound Spleen Neuromodulation Group

Experimental group

Description:

Patients receive standard septic shock care plus twice-daily non-invasive focused ultrasound stimulation over the spleen for five consecutive days, using a portable ultrasound neuromodulation device.

Treatment:

Procedure: Focused Ultrasound Spleen Neuromodulation

Control Group

No Intervention group

Description:

Patients receive standard care for septic shock according to current clinical guidelines, without focused ultrasound spleen stimulation.