[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598058":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":26,"studyPopulation":27,"armGroups":28,"interventions":11,"overallOfficials":11,"centralContacts":32,"locations":38,"responsibleParty":52,"collaborators":11,"id":56,"slug":11,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":11,"enrollmentInfo":65,"targetDuration":68,"studyType":69,"phases":11,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":76,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"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.",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Rate of compliance with sepsis bundle elements","This outcome quantifies the compliance rate, defined as the proportion of patients who completed all required sepsis bundle elements within the assigned 1-, 3-, or 6-hour window from time zero (time of sepsis recognition). Compliance rate is calculated as the number of patients who completed all clinically indicated bundle elements within the assigned time frame divided by the total number of eligible patients. The bundle elements include serum lactate measurement, blood culture collection prior to antibiotic administration, initiation of intravenous antibiotics, and administration of intravenous crystalloids for patients with hypotension or lactate levels greater than 4 mmol\u002FL.","Patient compliance with sepsis bundles will be assessed within 24 hours after ICU admission.",{"measure":19,"description":11,"timeFrame":20},"ICU mortality","From ICU admission to ICU discharge or death, up to 28 days",{"measure":22,"description":11,"timeFrame":12},"Ventilator-free days",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":24,"timePerspective":25,"maskingInfo":11},"CASE_ONLY","PROSPECTIVE","Sepsis is a major public health challenge in China and remains one of the leading causes of intensive care unit (ICU) admissions, accounting for approximately 20.6% of all ICU cases. However, longitudinal real-world data on adherence to clinical guidelines and associated patient outcomes remain limited. This multicenter observational registry is designed to systematically capture real-world management data from adult ICU patients diagnosed with sepsis according to Sepsis-3.0 criteria. The study will assess current treatment practices and document infection types, anatomical sites, pathogen profiles, and key clinical outcomes. By examining the relationship between treatment patterns and outcomes, this study aims to generate actionable evidence to improve the quality of sepsis care in China. The findings will help identify practice variability, support updates to national guidelines, and promote standardized, evidence-based management across the country.","Patients diagnosed with sepsis (Sepsis-3 criteria) upon ICU admission",[29],{"label":30,"type":11,"description":31,"interventionNames":11},"Sepsis Group","The sepsis group comprised patients diagnosed with sepsis (Sepsis-3 criteria).",[33],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"Professor Liu Songqiao","CONTACT","+86 25 83262553","liusongqiao@ymail.com",[39],{"facility":40,"status":11,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":11},"Zhongda hospital, Southeast University","Nanjing","Jiangsu","210009","China","CN",{"type":47,"coordinates":48},"Point",[49,50],118.77778,32.06167,{"lat":50,"lon":49},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Songqiao Liu","Prof","100598058",false,"NCT07066553","Outcomes of Sepsis Patients in China (CHINA-SEP)","Outcomes of Sepsis Patients in China: A Registry","CHINA-SEP","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":66,"type":67},5775,"ESTIMATED","28 Days","OBSERVATIONAL","Sepsis poses a significant public health challenge in China. However, longitudinal real-world evidence on guideline adherence and patient outcomes remains scarce. This registry aims to address these gaps by systematically capturing guideline-concordant treatment patterns and associated outcomes in ICU patients diagnosed according to Sepsis-3.0 criteria across diverse settings, thereby generating actionable evidence to improve the quality of sepsis care nationwide.",[72],"Sepsis",[44,72,74,75],"Intensive Care Unit","Outcomes","NOT_YET_RECRUITING","2025-07-14",{"date":79,"type":80},"2025-07-15","ACTUAL",{"date":82,"type":67},"2025-07-18",{"date":84,"type":67},"2027-08",{"name":5,"class":6},1]