[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spleen-neuromodulation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spleen-neuromodulation":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100592197","focused-ultrasound-spleen-stimulation-and-inflammation-in-septic-shock-100592197",false,"NCT06990295","Focused Ultrasound Spleen Stimulation and Inflammation in Septic Shock","Effects of Focused Ultrasound Spleen Neuromodulation on Inflammatory Cytokine Levels in Patients With Septic Shock: A Randomized Controlled Pilot Trial","Inclusion Criteria:\n\n* Age ≥ 18 years, regardless of sex\n* 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.\n* Admitted to the ICU within 24 hours of septic shock diagnosis\n* Expected to require intensive care for at least 72 hours\n* Informed consent obtained from the patient or legal representative\n\nExclusion Criteria:\n\n* Known pregnancy or breastfeeding\n* Participation in another interventional clinical trial within 30 days\n* Known immunodeficiency or ongoing immunosuppressive therapy\n* Malignancy with life expectancy \\\u003C 6 months\n* Contraindications to focused ultrasound (e.g., splenic trauma, splenectomy, local skin infection)\n* Do-not-resuscitate (DNR) order or expected death within 24 hours\n* Any other condition deemed unsuitable for participation by the investigators","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","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.\n\nEligibility Criteria:\n\nAdults 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\n\nStudy Protocol:\n\nParticipants will be randomly assigned to one of two groups:\n\nIntervention Group: Will receive standard septic shock care plus twice-daily focused ultrasound stimulation over the spleen for five days, using a portable device.\n\nControl 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.\n\nOutcome Measures:\n\nPrimary: 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\u002Ftolerability of the intervention.",[26,27,28,29,30],"Septic Shock","Inflammatory Cytokines","Spleen Neuromodulation","Focused Ultrasound","Critical Care",[26,29,28,27,30,32,33],"Immune Modulation","Pilot Study","RECRUITING","2026-05-15",{"date":37,"type":38},"2026-05-19","ACTUAL",{"date":40,"type":38},"2025-07-25",{"date":42,"type":20},"2026-12-31",{"name":44,"class":45},"First Affiliated Hospital of Wannan Medical College","OTHER"]