[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629140":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":50,"studyPopulation":50,"armGroups":61,"interventions":72,"overallOfficials":50,"centralContacts":82,"locations":50,"responsibleParty":88,"collaborators":50,"id":92,"slug":50,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":50,"enrollmentInfo":101,"targetDuration":50,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":113,"whyStopped":50,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":50},{"fullName":5,"class":6},"Sichuan Academy of Medical Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"Heart Rate Variability (HRV)","Heart rate variability will be assessed using continuous electrocardiographic monitoring. The primary HRV parameter analyzed will be the standard deviation of normal-to-normal intervals (SDNN).","From enrollment to the end of treatment at 48 hours",[14,17,20,24,28,32,35,38,42,46],{"measure":15,"description":16,"timeFrame":12},"Change in Sequential Organ Failure Assessment (SOFA) Score","The change in Sequential Organ Failure Assessment (SOFA) score from baseline to 48 hours will be used to evaluate organ dysfunction.",{"measure":18,"description":19,"timeFrame":12},"Interleukin-6 (IL-6) level","Change in plasma IL-6 levels from baseline to 48 hours",{"measure":21,"description":22,"timeFrame":23},"ICU length of stay","Duration of ICU stay for each participant","From enrollment to ICU discharge or 90 days, whichever occurs first",{"measure":25,"description":26,"timeFrame":27},"Duration of Mechanical Ventilation","Total duration of invasive mechanical ventilation during the first 48 hours after enrollment.","From randomization until successful liberation from mechanical ventilation, assessed up to 28 days.",{"measure":29,"description":30,"timeFrame":31},"Requirement for Renal Replacement Therapy (RRT)","Number of participants requiring renal replacement therapy during the first 48 hours after enrollment.","From randomization to 28 days after randomization.",{"measure":33,"description":34,"timeFrame":12},"Tumor necrosis factor-α (TNF-α) level","Change in plasma TNF-α levels from baseline to 48 hours",{"measure":36,"description":37,"timeFrame":12},"Procalcitonin (PCT) clearance","Percentage change in PCT levels relative to baseline",{"measure":39,"description":40,"timeFrame":41},"28-day all-cause mortality","Proportion of participants who die from any cause within 28 days of enrollment","From enrollment to 28 days",{"measure":43,"description":44,"timeFrame":45},"90-day all-cause mortality","Proportion of participants who die from any cause within 90 days of enrollment","From enrollment to 90 days",{"measure":47,"description":48,"timeFrame":49},"Incidence of new-onset organ dysfunction","Number of participants developing new organ dysfunction during the study period","From enrollment to 90 days or ICU\u002Fhospital discharge, whichever occurs first",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":54,"observationalModel":50,"timePerspective":50,"maskingInfo":55},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":56,"maskingDescription":50,"whoMasked":57},"TRIPLE",[58,59,60],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[62,67],{"label":63,"type":64,"description":50,"interventionNames":65},"ARM1","PLACEBO_COMPARATOR",[66],"Drug: Placebo",{"label":68,"type":69,"description":50,"interventionNames":70},"Dexmedetomidine","ACTIVE_COMPARATOR",[71],"Drug: Dexmedetomidine (DEX)",[73,78],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":50},"DRUG","Dexmedetomidine (DEX)","0.5 micrograms per kilogram per hour (0.5 μg\u002Fkg\u002Fh)",[68],{"type":74,"name":79,"description":80,"armGroupLabels":81,"otherNames":50},"Placebo","0.9% Sodium Chloride Injection",[63],[83],{"name":84,"role":85,"phone":86,"phoneExt":50,"email":87},"rongan Liu","CONTACT","+8615928731511","35279240@qq.com",{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"PRINCIPAL_INVESTIGATOR","Rongan Liu","Associate Chief Physician, Intensive Care Unit","100629140",false,"NCT07470775","Early Dexmedetomidine and Sympathetic Regulation in Sepsis","A Prospective Study on the Effects of Early Dexmedetomidine Administration on Sympathetic Nervous System Activity, Pathophysiological Mechanisms, and Clinical Outcomes in Sepsis","DEX-SNS-SEPSIS","Inclusion Criteria:\n\nAge ≥ 18 year Septic shock defined by Sepsis-3 criteria Enrollment within 24 hours of diagnosis APACHE II score \\> 10\n\nExclusion Criteria:\n\nPregnancy or lactation Second- or third-degree atrioventricular block Persistent bradycardia (HR \\\u003C50 bpm) requiring intervention Hypersensitivity to dexmedetomidine Norepinephrine dose \\>0.5 μg\u002Fkg\u002Fmin End-stage disease or life expectancy \\\u003C72 hours Any condition deemed unsuitable by the investigator","ALL","18 Years",{"count":102,"type":103},168,"ESTIMATED","INTERVENTIONAL",[106],"PHASE4","The goal of this clinical trial is to learn whether early administration of dexmedetomidine can improve autonomic nervous system regulation and clinical outcomes in adult patients with septic shock. It will also evaluate the safety of dexmedetomidine in this population.\n\nThe main questions it aims to answer are:\n\nDoes early dexmedetomidine improve sympathetic nervous system activity, as measured by heart rate variability (HRV) and blood pressure variability (BPV)?\n\nDoes dexmedetomidine reduce endogenous catecholamine levels and vasopressor requirements?\n\nDoes early autonomic modulation improve organ function and survival outcomes in septic shock? Researchers will compare dexmedetomidine to a placebo (normal saline) to determine whether dexmedetomidine improves hemodynamic stability and prognosis in patients with septic shock.\n\nParticipants will:\n\nBe randomly assigned to receive dexmedetomidine (0.5 μg\u002Fkg\u002Fh) or placebo by continuous intravenous infusion for 48 hours\n\nUndergo continuous ECG and invasive blood pressure monitoring\n\nHave blood samples collected at predefined time points to measure inflammatory markers and endogenous catecholamine levels\n\nBe assessed for organ function, vasopressor use, and perfusion parameters during the first 48 hours\n\nBe followed up for 28-day and 90-day survival outcomes",[109,110],"Sepsis","Septic Shock",[68,112,110],"Sympathetic Nervous System","NOT_YET_RECRUITING","2026-03-10",{"date":116,"type":117},"2026-03-13","ACTUAL",{"date":119,"type":103},"2026-03-01",{"date":121,"type":103},"2028-03-01",{"name":5,"class":6}]