Clinical trial NCT06990295: Focused Ultrasound Spleen Stimulation and Inflammation in Septic Shock
Official title: Effects of Focused Ultrasound Spleen Neuromodulation on Inflammatory Cytokine Levels in Patients With Septic Shock: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Septic Shock
Inflammatory Cytokines
Spleen Neuromodulation
Focused Ultrasound
Critical Care
Keywords: Septic Shock
Focused Ultrasound
Spleen Neuromodulation
Inflammatory Cytokines
Critical Care
Immune Modulation
Pilot Study
Lead sponsor: First Affiliated Hospital of Wannan Medical College
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Inflammatory Cytokine Levels
timeFrame: Baseline, Day 3, and Day 5
Secondary outcomes:
measure: Change in Lymphocyte Subpopulations
timeFrame: Baseline, Day 3, and Day 5
measure: Change in Organ Function (SOFA Score)
timeFrame: Baseline and Day 5
measure: ICU Length of Stay (LOS)
timeFrame: Through study completion (anticipated average 14 days)
measure: 28-day mortality rate
timeFrame: 28 days
Other outcomes:
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