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Focused Ultrasound Spleen Stimulation and Inflammation in Septic Shock

ConditionsSeptic ShockInflammatory CytokinesSpleen NeuromodulationFocused UltrasoundCritical Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Wannan Medical College

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Focused Ultrasound Spleen Neuromodulation

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Focused Ultrasound Spleen Neuromodulation GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Inflammatory Cytokine Levels

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.

Time frame
Baseline and Day 5

Secondary outcomes

1

Change in Lymphocyte Subpopulations

Change in plasma levels of key inflammatory cytokines \[e.g., CD3⁺T cells (%)、CD3⁺T cells (cells/μL)、CD3-CD19⁺B cells (%)、CD3-CD19⁺B cells (cells/μL)、CD3⁺CD4⁺T cells (%)、CD3⁺CD4⁺T cells (cells/μL)、CD3⁺CD8⁺T cells (%)、CD3⁺CD8⁺T cells (cells/μL)、CD3-(CD16⁺CD56⁺)NK cells (%)、CD3-(CD16⁺CD56⁺)NK cells (cells/μL)\] from baseline to Day 5 after randomization.

Time frame
Baseline and Day 5
2

Change in Organ Function (SOFA Score)

Difference in Sequential Organ Failure Assessment (SOFA) scores from baseline to Day 5. The SOFA score ranges from 0 to 24, with higher scores indicating worse organ function and a poorer prognosis.

Time frame
Baseline and Day 5
3

ICU Length of Stay (LOS)

Duration of ICU hospitalization in days.

Time frame
Through study completion (anticipated average 14 days)
4

28-day mortality rate

All-cause mortality within 28 days after randomization.

Time frame
28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Wannan Medical College

Lead sponsor

Wuhu City Second People's Hospital

Collaborator

Source ClinicalTrials.gov
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