Focused Ultrasound Spleen Stimulation and Inflammation in Septic Shock

Launched by FIRST AFFILIATED HOSPITAL OF WANNAN MEDICAL COLLEGE · May 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new, non-invasive treatment using focused ultrasound to help patients with septic shock, a serious condition that causes severe inflammation and organ problems. The main goal is to see if this ultrasound treatment can lower harmful inflammation in the body by stimulating the spleen, an organ that plays a role in immune response. If successful, this approach could help improve recovery for patients in critical care.

To participate, individuals must be at least 18 years old, diagnosed with septic shock, and recently admitted to the intensive care unit (ICU). They should expect to stay in the ICU for at least 72 hours. Participants will be randomly assigned to either receive standard care along with the ultrasound treatment for five days or just the standard care alone. Throughout the study, researchers will take blood samples to monitor inflammation levels and assess overall health and recovery. This trial aims to explore a promising way to manage inflammation and potentially improve outcomes for patients facing septic shock.

Gender

ALL

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