[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592197":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":51,"collaborators":54,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":18,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":18,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":79,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"First Affiliated Hospital of Wannan Medical College","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Focused Ultrasound Spleen Neuromodulation Group","EXPERIMENTAL","Patients receive standard septic shock care plus twice-daily non-invasive focused ultrasound stimulation over the spleen for five consecutive days, using a portable ultrasound neuromodulation device.",[13],"Procedure: Focused Ultrasound Spleen Neuromodulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Patients receive standard care for septic shock according to current clinical guidelines, without focused ultrasound spleen stimulation.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Focused Ultrasound Spleen Neuromodulation","A portable focused ultrasound device is used to stimulate the spleen area under real-time imaging guidance. Each session lasts approximately 20 minutes, repeated twice daily for five days.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Qiancheng Xu","CONTACT","86-18297529106","qianchengxu@wnmc.edu.cn",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)","RECRUITING","Wuhu","Anhui","241001","China","CN",{"type":41,"coordinates":42},"Point",[43,44],118.42947,31.35259,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":49,"phoneExt":18,"email":50},"Shengsheng Tao","86-18315329399","taoshengsheng@yjsyy.com",{"type":52,"investigatorFullName":27,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Principal Investigator",[55],{"name":56,"class":6},"Wuhu City Second People's Hospital","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":67,"type":68},40,"ESTIMATED","INTERVENTIONAL",[71],"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.",[74,75,76,77,78],"Septic Shock","Inflammatory Cytokines","Spleen Neuromodulation","Focused Ultrasound","Critical Care",[74,77,76,75,78,80,81],"Immune Modulation","Pilot Study","2026-05-15",{"date":84,"type":85},"2026-05-19","ACTUAL",{"date":87,"type":85},"2025-07-25",{"date":89,"type":68},"2026-12-31",{"name":5,"class":6},1]