NCT06990295 Focused Ultrasound Spleen Stimulation and Inflammation in Septic Shock
| NCT ID | NCT06990295 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Wannan Medical College |
| Condition | Septic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-07-25 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-07-25 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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 5. Secondary: Changes in organ function (SOFA score), ICU length of stay, 28-day survival, and safety/tolerability of the intervention.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06990295 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06990295 currently recruiting?
Yes, NCT06990295 is actively recruiting participants. Contact the research team at qianchengxu@wnmc.edu.cn for enrollment information.
Where is the NCT06990295 trial being conducted?
This trial is being conducted at Wuhu, China.
Who is sponsoring the NCT06990295 clinical trial?
NCT06990295 is sponsored by First Affiliated Hospital of Wannan Medical College. The trial plans to enroll 40 participants.