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

Overview

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.

Detailed description

This randomized, controlled pilot study investigates the safety and efficacy of focused ultrasound neuromodulation of the spleen in adult patients diagnosed with septic shock. Participants will be randomized into two groups: one receiving standard of care and the other receiving additional targeted spleen stimulation via focused ultrasound. The intervention involves twice-daily sessions over five days, utilizing a portable device designed to deliver precise, non-invasive ultrasound energy to the splenic region. The rationale for targeting the spleen stems from its role in immunomodulation, particularly in the regulation of inflammatory cytokines involved in septic shock pathophysiology.

Blood samples will be systematically collected at baseline and Day 5 to quantify serum levels of key inflammatory cytokines, including tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), interleukin-6 (IL-6), and interleukin-10 (IL-10), using validated immunoassays. In addition, lymphocyte subpopulations will be analyzed via flow cytometry to assess immune cell dynamics. Organ dysfunction will be evaluated using the Sequential Organ Failure Assessment (SOFA) score at specified time points to monitor changes in organ status. Data on ICU length of stay and 28-day mortality will be collected to evaluate clinical outcomes. Adverse events related to the intervention will be documented to assess safety and tolerability.

By investigating the immunomodulatory effects of focused ultrasound spleen neuromodulation, this study aims to establish preliminary safety and efficacy data for a potentially transformative therapeutic modality in septic shock management.

Interventions

• Procedure 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.

Primary outcome measures

• Change in Inflammatory Cytokine Levels [Time frame: Baseline and Day 5]

Secondary outcome measures (4)

• Change in Lymphocyte Subpopulations [Time frame: Baseline and Day 5]
• Change in Organ Function (SOFA Score) [Time frame: Baseline and Day 5]
• ICU Length of Stay (LOS) [Time frame: Through study completion (anticipated average 14 days)]
• 28-day mortality rate [Time frame: 28 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medic — Wuhu

Identifiers

NCT: NCT06990295 · 202580

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗