Safety and Effectiveness of Focused Ultrasound Stimulation of the Spleen in Adults With Septic Shock A Randomized Pilot Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of focused ultrasound spleen neuromodulation in adults with septic shock, a serious condition marked by excessive inflammation and organ failure. This randomized controlled pilot study aims to see if non-invasive ultrasound stimulation of the spleen can lower levels of harmful inflammatory cytokines. The spleens role in immune regulation makes it a promising target for this new approach. Participants will be randomly placed into two groups. One group will receive standard septic shock care plus focused ultrasound stimulation over the spleen twice daily for five days using a portable device. The other group will receive standard care without ultrasound stimulation. Blood samples will be taken at the start and on Day 5 to measure inflammatory cytokines like TNF-alpha, IL-1beta, IL-6, and IL-10. Other measures include immune cell analysis, organ function scores, length of ICU stay, 28-day survival, and monitoring for any side effects. During the study, participants will have blood tests to track immune responses and organ function assessed through the SOFA score. Researchers will also record how long patients stay in the ICU and their survival at 28 days. Safety and tolerability of the ultrasound treatment will be closely monitored. The total observation includes at least five days of treatment plus follow-up for clinical outcomes, aiming to gather preliminary data on this novel therapys impact.

Focused Ultrasound Spleen Stimulation and Inflammation in Septic Shock