[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647605":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":39,"locations":45,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":96,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Semmelweis University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Medical Therapy (Group A)","ACTIVE_COMPARATOR","Patients will receive standard medical therapy (SMT) according to local protocols based on international 'Surviving Sepsis Campaign' guidelines.",[13],"Other: Standard Medical Therapy (SMT)",{"label":15,"type":16,"description":17,"interventionNames":18},"CytoSorb Therapy (Group B)","EXPERIMENTAL","Patients will receive standard medical therapy plus a fixed 24-hour continuous hemoadsorption treatment utilizing two sequential CytoSorb cartridges (exchanged at the 12-hour mark).",[19],"Device: CytoSorb hemoadsorption",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","CytoSorb hemoadsorption","Target blood flow rate of 1.5 ml\u002Fkg\u002Fmin, implemented either as a standalone extracorporeal treatment or integrated into a CRRT circuit (CVVHDF mode, preferably with regional citrate anticoagulation).",[15],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Medical Therapy (SMT)","Standard Medical Therapy according to local protocols based on the current international 'Surviving Sepsis Campaign' guidelines.",[9],[32,36],{"name":33,"affiliation":34,"role":35},"Zsolt Molnár, Prof. Dr.","Department of Anaesthesiology and Intensive Therapy, Semmelweis University, Budapest, Hungary","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Péter Hegyi, Prof. Dr.","Centre for Translational Medicine, Semmelweis University, Budapest, Hungary",[40],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Tamás Tóth, Dr.","CONTACT","+36305399474","tomesz9@gmail.com",[46],{"facility":47,"status":26,"city":48,"state":26,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Semmelweis University, Department of Anaesthesiology and Intensive Therapy (Intenzív Terápiás Klinika).","Budapest","1082","Hungary","HU",{"type":53,"coordinates":54},"Point",[55,56],19.04045,47.49835,{"lat":56,"lon":55},[59],{"name":33,"role":42,"phone":60,"phoneExt":26,"email":61},"+36-1-459-1500","molnar.zsolt1@semmelweis.hu",{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[65],{"name":66,"class":67},"Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA","OTHER_GOV","100647605","effects-of-hemoadsorption-on-vascular-integrity-in-septic-shock-100647605",false,"NCT07711197","Effects of Hemoadsorption on Vascular Integrity in Septic Shock","Effects of Hemoadsorption on Vascular Integrity in Septic Shock (ADSORP-VIP Trial): Protocol of a Prospective, Randomised, Controlled Trial","ADSORP-VIP","Inclusion Criteria:\n\n* Septic shock as defined by Sepsis-3 criteria.\n* Serum lactate levels \\>2 and \\\u003C8 mmol\u002FL at screening.\n* Fluid unresponsiveness: Objectively confirmed via dynamic tests or fluid challenges following initial resuscitation.\n* Vasopressor Dose Threshold: Norepinephrine base equivalent (NEE) dose \\> 0.5 µg\u002Fkg\u002Fmin.\n* Systemic corticosteroid treatment on board for at least 30 minutes.\n* Tissue perfusion impairment: Persistently elevated serum lactate AND\u002FOR prolonged capillary refill time (\\> 3 seconds) despite standard therapy.\n* Alternative causes of shock (e.g., obstructive or cardiogenic) must be ruled out using critical care ultrasonography (CCUS).\n* Arterial, central venous catheters and an invasive hemodynamic device (PiCCO, Getinge) in place.\n* Inclusion within a maximum of 12 hours after the onset of vasopressor need.\n* High likelihood of a dysregulated immune response (PCT ≥ 5 ng\u002FmL AND\u002FOR IL-6 ≥ 1000 pg\u002FmL AND\u002FOR Ferritin ≥ 1000 ng\u002FmL).\n* Written informed, retrospective or prospective consent.\n\nExclusion Criteria:\n\n* Patients under 18 years of age and over 80.\n* Unlikely to survive for 24 hours (Moribund).\n* Pregnancy.\n* SOFA-2 score ≥ 16 at ICU admission.\n* Source control is uncertain.\n* Thrombocytopenia (\\\u003C20,000\u002FµL).\n* Criteria of standard guideline-based medical treatment not exhausted.\n* End-stage organ failure (chronic renal failure (estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m2), chronic liver failure (MELD Score \\>30, ChildPugh score class C.), chronic heart failure (New York Heart Association class IV.); severe chronic pulmonary disease (chronic obstructive pulmonary disease: GOLD D)).\n* Expected need to disconnect CytoSorb therapy for more than 2 hours (e.g., surgery, CT transfer).","ALL","18 Years","80 Years",{"count":80,"type":81},110,"ESTIMATED","INTERVENTIONAL",[84],"NA","This study aims to investigate the effects of adjunctive CytoSorb hemoadsorption therapy versus standard medical treatment on endothelial dysfunction in patients with refractory septic shock. The investigators hypothesize that hemoadsorption mitigates endothelial and glycocalyx injury by removing inflammatory mediators and other injurious circulating molecules, promoting hemodynamic stabilization.",[87],"Septic Shock",[89,90,91,92,93,94,95],"sepsis","septic shock","hemoadsorption","CytoSorb","endothelial dysfunction","syndecan-1","vasoplegia","NOT_YET_RECRUITING","2026-07-14",{"date":99,"type":100},"2026-07-17","ACTUAL",{"date":102,"type":81},"2026-09-01",{"date":104,"type":81},"2029-01-01",{"name":5,"class":6},1]