[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598315":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":24,"studyPopulation":25,"armGroups":26,"interventions":11,"overallOfficials":11,"centralContacts":30,"locations":36,"responsibleParty":50,"collaborators":11,"id":54,"slug":11,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":11,"enrollmentInfo":63,"targetDuration":66,"studyType":67,"phases":11,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":74,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Southeast University, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"28-day all-cause mortality",null,"28 days after enrollment",[14,17,19],{"measure":15,"description":11,"timeFrame":16},"ICU mortality","From Intensive Care Unit (ICU) admission to ICU discharge or death, up to 28 days.",{"measure":18,"description":11,"timeFrame":12},"Ventilator-free days",{"measure":20,"description":11,"timeFrame":12},"ICU-free days within 28 days",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":22,"timePerspective":23,"maskingInfo":11},"CASE_ONLY","PROSPECTIVE","Sepsis is a life-threatening syndrome caused by a dysregulated response to infection, affecting an estimated 49 million people and claiming 11 million lives globally each year. Xuebijing injection (XBJ) has demonstrated efficacy in improving outcomes. A large multicenter randomized controlled trial (EXIT-SEP) confirmed that XBJ significantly reduces 28-day mortality. However, the trial population was relatively selected (aged 18-75 years, SOFA score 2-13), leaving its effectiveness in complex, real-world settings unclear. Therefore, further investigation of XBJ's impact in broader clinical practice is essential.","Patients diagnosed with sepsis (Sepsis-3 criteria) upon ICU admission",[27],{"label":28,"type":11,"description":29,"interventionNames":11},"Xuebijing Group","The Xuebijing group consisted of sepsis patients who received both Xuebijing injection and guideline-concordant therapy. Researchers did not provide any additional interventions, but instead observed and documented the clinical outcomes and treatment effects of Xuebijing injection in combination with standard therapy.",[31],{"name":32,"role":33,"phone":34,"phoneExt":11,"email":35},"Professor Liu Songqiao","CONTACT","+86 25 83262553","liusongqiao@ymail.com",[37],{"facility":38,"status":11,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":11},"Zhongda hospital, Southeast University","Nanjing","Jiangsu","210009","China","CN",{"type":45,"coordinates":46},"Point",[47,48],118.77778,32.06167,{"lat":48,"lon":47},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Songqiao Liu","Prof","100598315",false,"NCT07069894","Effect of Xuebijing InjecTion on Outcomes in Sepsis Patients Under Real-World Conditions（EXIT-SEP REAL）","Effect of Xuebijing InjecTion on Outcomes in Sepsis Patients Under Real-World Conditions: A Patient Registry","EXIT-SEP REAL","Inclusion Criteria:\n\n* Hospitalized patients aged ≥18 years\n* Sepsis diagnosis meeting Sepsis-3 criteria\n* Informed consent signed by patient or legally authorized representative\n\nExclusion Criteria:\n\n* Patients with a prior history of sepsis\n* Sepsis diagnosis \\>48 hours prior to enrollment\n* Current participation in clinical trial","ALL","18 Years",{"count":64,"type":65},5400,"ESTIMATED","28 Days","OBSERVATIONAL","Xuebijing injection (XBJ) showed proven efficacy in the EXIT-SEP trial (NCT03238742), lowering 28-day mortality. However, its real-world effectiveness requires validation due to the trial's strict criteria. Broader clinical evaluation is imperative.",[70],"Sepsis",[70,72,73],"Xuebijing injection","Intensive Care Unit","NOT_YET_RECRUITING","2025-07-15",{"date":77,"type":78},"2025-07-17","ACTUAL",{"date":80,"type":65},"2025-08-01",{"date":82,"type":65},"2027-09",{"name":5,"class":6},1]