Focused Ultrasound Spleen Stimulation and Inflammation in Septic Shock

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, Day 3, 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.