Status:
NOT_YET_RECRUITING
Focused Ultrasound Spleen Stimulation and Inflammation in Septic Shock
Lead Sponsor:
First Affiliated Hospital of Wannan Medical College
Collaborating Sponsors:
Wuhu City Second People's Hospital
Conditions:
Septic Shock
Inflammatory Cytokines
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 o...
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 ran...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 2 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06990295
Start Date
July 3 2025
End Date
July 2 2026
Last Update
July 4 2025
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