NCT06990295

Focused Ultrasound Spleen Stimulation and Inflammation in Septic Shock

Not yet recruiting NA Last updated 4 July 2025

What this trial tests

NA trial testing Focused Ultrasound Spleen Neuromodulation in Septic Shock in 40 participants. Not yet recruiting.

Timeline

3 July 2025

Primary endpoint
2 July 2026

2 July 2026

Quick facts

Lead sponsor	First Affiliated Hospital of Wannan Medical College
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	3 July 2025
Primary completion	2 July 2026
Estimated completion	2 July 2026

Drugs / interventions tested

• Focused Ultrasound Spleen Neuromodulation

Conditions studied

• Septic Shock — all drugs for Septic Shock →
• Inflammatory Cytokines — all drugs for Inflammatory Cytokines →
• Spleen Neuromodulation — all drugs for Spleen Neuromodulation →
• Focused Ultrasound — all drugs for Focused Ultrasound →

Sponsor

First Affiliated Hospital of Wannan Medical College

Who can join

18 and older, any sex, with Septic Shock or Inflammatory Cytokines. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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, Day 3, 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 3 and Day 5. Secondary: Changes in organ function (SOFA score), ICU length of stay, 28-day survival, and safety/tolerability of the intervention.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.