EICHORCondition: Septic Shock · Inflammatory Cytokines · Spleen Neuromodulation · Sponsor: First Affiliated Hospital of Wannan Medical College
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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.
This description comes directly from the study's public registry record.
Qiancheng Xu · 86-18297529106 · qianchengxu@wnmc.edu.cn
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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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College) | Wuhu, Anhui, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06990295