[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659542":3},{"organization":4,"outcomesModule":7,"designInfo":66,"detailedDescription":74,"studyPopulation":71,"armGroups":75,"interventions":82,"overallOfficials":88,"centralContacts":93,"locations":100,"responsibleParty":120,"collaborators":71,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":71,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":71,"enrollmentInfo":131,"targetDuration":71,"studyType":134,"phases":135,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":143,"whyStopped":71,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":61},[9],{"measure":10,"description":11,"timeFrame":12},"Immediate change in plasma IL-6 concentration after hemoadsorption","The primary outcome is the immediate change in plasma IL-6 concentration from the pre-hemoadsorption baseline (T0) to immediately after completion of hemoadsorption (T1).","Baseline before initiation of hemoadsorption (T0) and immediately after completion of hemoadsorption (T1)",[14,17,21,25,29,33,37,41,45,49,53,57],{"measure":15,"description":16,"timeFrame":12},"Acute change in plasma proteomic profile after hemoadsorption","Treatment-associated changes in plasma protein expression profiles from T0 to T1, analyzed using TMT-based quantitative proteomics.",{"measure":18,"description":19,"timeFrame":20},"Changes in inflammatory markers","Changes in TNF-α, IL-8, and other prespecified inflammatory biomarkers across T0, T1, and T2.","Baseline before hemoadsorption (T0), immediately after completion of hemoadsorption (T1), and approximately 24 hours after treatment (T2)",{"measure":22,"description":23,"timeFrame":24},"Change in SOFA score","Change in Sequential Organ Failure Assessment (SOFA) score","Baseline, 24 hours, 48 hours, and 7 days after treatment",{"measure":26,"description":27,"timeFrame":28},"28 day all-cause mortality","Death from any cause by Day 28 after enrollment.","Up to 28 days.",{"measure":30,"description":31,"timeFrame":32},"ICU mortality (death before ICU discharge)","Death occurring before ICU discharge during the ICU stay in which the participant is enrolled.","From ICU admission to ICU discharge or death, up to 90 days.",{"measure":34,"description":35,"timeFrame":36},"Length of ICU stay","Number of days from ICU admission to ICU discharge.","From ICU admission to ICU discharge, up to 90 days.",{"measure":38,"description":39,"timeFrame":40},"Length of hospital stay","Number of days from hospital admission to hospital discharge.","From hospital admission to hospital discharge, up to 90 days.",{"measure":42,"description":43,"timeFrame":44},"Hemodynamic stability","Changes in mean arterial pressure (MAP) and vasopressor requirements","Baseline, 24 hours, 48 hours after treatment",{"measure":46,"description":47,"timeFrame":48},"Renal replacement therapy use","Requirement for and duration of renal replacement therapy during the index hospitalization.","During the index hospitalization, up to 30 days",{"measure":50,"description":51,"timeFrame":52},"Ventilator-free days to Day 28","Days free from mechanical ventilation within 28 days.","Up to 28 days",{"measure":54,"description":55,"timeFrame":56},"Sustained change in plasma IL-6 concentration at 24 hours","Change in plasma IL-6 concentration from T0 to T2 to assess persistence or rebound of the early IL-6 response after hemoadsorption.","Baseline before hemoadsorption (T0) and approximately 24 hours after treatment (T2)",{"measure":58,"description":59,"timeFrame":60},"90-day all-cause mortality","Death from any cause by Day 90 after enrollment.","Up to 90 days",[62],{"measure":63,"description":64,"timeFrame":65},"Treatment-related adverse events","Frequency and severity of adverse events related to hemoperfusion therapy, including bleeding events, infection, and hypotension, graded according to CTCAE v5.0 criteria.","During treatment and through Day 28 after enrollment (or until hospital discharge, whichever occurs first).",{"allocation":67,"interventionModel":68,"interventionModelDescription":69,"primaryPurpose":70,"observationalModel":71,"timePerspective":71,"maskingInfo":72},"NA","SINGLE_GROUP","This is a single-arm study in which all participants receive hemoadsorption therapy. Each participant serves as their own control. The primary within-participant comparison is between the pre-hemoadsorption baseline (T0) and the measurement obtained immediately after completion of hemoadsorption (T1). Measurements obtained approximately 24 hours after treatment (T2) will be used to assess persistence or rebound of biomarker changes.","TREATMENT",null,{"masking":73,"maskingDescription":71,"whoMasked":71},"NONE","Sepsis is a life-threatening syndrome caused by a dysregulated host response to infection and is associated with substantial morbidity and mortality in critically ill patients. Elevated circulating inflammatory mediators, including interleukin-6 (IL-6), are associated with disease severity and adverse clinical outcomes. Hemoadsorption is an extracorporeal blood purification approach in which whole blood passes through an adsorption cartridge to reduce circulating inflammatory mediators. Unlike plasma adsorption techniques, plasma separation is not required.\n\nThis single-center, prospective, single-arm study will enroll 30 adult patients with sepsis at Zhongshan Hospital, Fudan University. After screening and written informed consent, eligible participants will undergo baseline clinical assessment followed by hemoadsorption therapy using the CA330 Cytokine Adsorption Column. Blood samples will be collected at three prespecified time points: baseline before initiation of hemoadsorption (T0), immediately after completion of hemoadsorption (T1), and approximately 24 hours after completion of hemoadsorption (T2). IL-6 and other inflammatory biomarkers will be assessed at T0, T1, and T2. Exploratory TMT-based quantitative proteomics will be performed on plasma samples collected at T0 and T1 to characterize acute treatment-associated molecular changes.\n\nContinuous renal replacement therapy (CRRT) and other organ-supportive treatments will be initiated according to routine clinical indications and standard ICU practice. CRRT is not required for study eligibility and, when used, will be recorded as concomitant therapy. Other treatments, including antimicrobial therapy, fluid resuscitation, vasopressors, mechanical ventilation, and additional organ support, will be provided according to the patient's clinical condition.\n\nThe primary outcome is the immediate change in plasma IL-6 concentration from the pre-hemoadsorption baseline (T0) to immediately after completion of hemoadsorption (T1). Secondary outcomes include the sustained change in IL-6 at approximately 24 hours (T2), changes in plasma proteomic profiles and other inflammatory biomarkers, Sequential Organ Failure Assessment (SOFA) scores, hemodynamic parameters, renal replacement therapy use, ventilator-free days, 28-day and 90-day all-cause mortality, ICU mortality, ICU length of stay, and hospital length of stay. Safety events associated with hemoadsorption, including bleeding, infection, and hypotension, will also be recorded.\n\nThe planned sample size is 30 participants. The sample size was determined based on an expected 30% within-participant reduction in IL-6 after hemoadsorption, with a two-sided alpha of 0.05 and statistical power of 80%, while allowing for participant dropout, specimen quality issues, and variability in IL-6 levels among patients with sepsis.\n\nWithin-participant changes in continuous variables will be assessed using paired statistical methods, including paired t-tests or Wilcoxon signed-rank tests, as appropriate. Plasma proteomic data will be analyzed to identify treatment-associated protein changes and associated biological pathways using pathway enrichment and protein-interaction analyses. Relationships between proteomic changes and clinical parameters will be explored using correlation analyses.\n\nParticipants will be followed during the index hospitalization and through Day 90 after enrollment. All-cause mortality will be assessed at Day 28 and Day 90.",[76],{"label":77,"type":78,"description":79,"interventionNames":80},"Hemoadsorption Arm","EXPERIMENTAL","Participants will receive CA330 hemoadsorption in addition to standard care for sepsis. Blood samples will be collected at T0 (before hemoadsorption), T1 (immediately after completion of hemoadsorption), and T2 (24 ±2 hours after treatment) for biomarker assessment. Plasma proteomics will be performed using samples collected at T0 and T1.",[81],"Device: Hemoperfusion with CA330 Cytokine Adsorption Column",[83],{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":71},"DEVICE","Hemoperfusion with CA330 Cytokine Adsorption Column","Patients will receive hemoadsorption therapy using the Cytokine Adsorption Column CA330 (Jafron Biomedical Co., Ltd., Zhuhai, China). During treatment, whole blood passes through an extracorporeal hemoperfusion circuit containing the adsorption cartridge. Circulating inflammatory mediators are removed by adsorption, and the treated blood is returned directly to the patient. Plasma separation is not performed. CRRT may be administered according to routine clinical indications and is not required for study participation. Standard-of-care therapy for sepsis will be provided throughout the study according to the treating team.Each index hemoadsorption session will last approximately 2-4 hours.",[77],[89],{"name":90,"affiliation":91,"role":92},"Ming Zhong, Ph.D","Fudan University","STUDY_CHAIR",[94,99],{"name":95,"role":96,"phone":97,"phoneExt":71,"email":98},"Ming Zhong","CONTACT","+8613817758167","zhong.ming@zs-hospital.sh.cn",{"name":95,"role":96,"phone":71,"phoneExt":71,"email":98},[101],{"facility":102,"status":71,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"Zhongshan Hospital, Fudan University","Shanghai","Shanghai Municipality","200032","China","CN",{"type":109,"coordinates":110},"Point",[111,112],121.45806,31.22222,{"lat":112,"lon":111},[115,118],{"name":116,"role":96,"phone":117,"phoneExt":71,"email":98},"Ming Zhong, Ph D","13817758167",{"name":116,"role":119,"phone":71,"phoneExt":71,"email":71},"PRINCIPAL_INVESTIGATOR",{"type":121,"investigatorFullName":71,"investigatorTitle":71,"investigatorAffiliation":71,"oldNameTitle":71,"oldOrganization":71},"SPONSOR","100659542","hope-sepsis-hemoadsorption-therapy-for-sepsis-100659542",false,"NCT07865585","HOPE-Sepsis: Hemoadsorption Therapy for Sepsis","Proteomic Analysis and Clinical Efficacy Evaluation of Hemoadsorption Therapy in Sepsis","Inclusion Criteria:\n\nAge ≥18 years. Sepsis (Sepsis-3): Diagnosis of sepsis according to Sepsis-3 criteria. Blood IL-6 \\>100 pg\u002FmL, Expected ICU stay \\>48 hours. Informed consent obtained from the patient or legally authorized representative\n\nExclusion Criteria:\n\nImmunosuppressed state, such as receiving immunosuppressive therapy or HIV infection.\n\nSevere coagulation dysfunction, including platelet count \\\u003C50 × 10⁹\u002FL or significantly prolonged PT\u002FAPTT.\n\nPre-existing chronic kidney disease or end-stage renal disease. Pregnancy or lactation. Refusal to participate in the study.","ALL","18 Years",{"count":132,"type":133},30,"ESTIMATED","INTERVENTIONAL",[67],"This is a single-center, prospective, single-arm, open-label study that will enroll 30 adult patients with sepsis at Zhongshan Hospital, Fudan University. All participants will receive CA330 hemoadsorption in addition to standard care. Blood samples will be collected at prespecified time points before hemoadsorption (T0), immediately after completion of hemoadsorption (T1), and approximately 24 hours after completion of hemoadsorption (T2) to evaluate changes in IL-6 and other inflammatory biomarkers. TMT-based quantitative proteomics will be performed on plasma samples collected at T0 and T1 to characterize acute treatment-associated molecular changes and explore their relationships with clinical outcomes.",[138],"Sepsis and Septic Shock",[140,141,142],"Proteomics","hemoperfusion (cytokine hemoadsorption)","Blood purification","NOT_YET_RECRUITING","2026-10-04",{"date":146,"type":147},"2026-10-08","ACTUAL",{"date":149,"type":133},"2026-10-01",{"date":151,"type":133},"2028-03-31",{"name":5,"class":6},1]