[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641441":3},{"organization":4,"outcomesModule":7,"designInfo":93,"detailedDescription":105,"studyPopulation":98,"armGroups":106,"interventions":129,"overallOfficials":146,"centralContacts":151,"locations":157,"responsibleParty":231,"collaborators":233,"id":243,"slug":244,"hasResults":245,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":245,"sex":251,"minAge":252,"maxAge":253,"enrollmentInfo":254,"targetDuration":98,"studyType":257,"phases":258,"briefSummary":260,"conditions":261,"keywords":263,"overallStatus":269,"whyStopped":98,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":279},{"fullName":5,"class":6},"Moscow Multidisciplinary Clinical Center \"Kommunarka\"","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":78},[9],{"measure":10,"description":11,"timeFrame":12},"SOFA (sequential organ failure assessment) score","MODS (multiple organ disfunction syndrome) dynamics majored by SOFA (sequential organ failure assessment) score. SOFA score ranges from 0 (best) to 24 (worst) points.","Assessed at 72 hours after hemoadsorption initiation",[14,18,21,24,27,30,33,37,40,43,46,49,51,53,57,60,64,67,70,74],{"measure":15,"description":16,"timeFrame":17},"Vasoactive Inotropic Score (VIS) dynamics","Vasoactive Inotropic Score (VIS) dynamics\n\nVIS = dopamine dose (mcg∕kg∕ min ) + dobutamine dose (mcg∕kg∕ min ) + 100 × epinephrine dose (mcg∕kg∕ min ) + 10 × milrinone dose (mcg∕kg∕ min ) + 10,000 × vasopressin dose (units∕kg∕ min )\n\n\\+ 100 × norepinephrine dose (mcg∕kg∕ min )","Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation",{"measure":19,"description":20,"timeFrame":17},"Norepinephrine dose dynamics","Norepinephrine dose dynamics (mcg\u002Fkg\u002Fmin)",{"measure":22,"description":23,"timeFrame":17},"Hemodynamic index dynamics","Hemodynamic index: Mean arterial pressure (MAP) to Vasoactive Inotropic Score (VIS);\n\nVIS = dopamine dose (mcg∕kg∕ min ) + dobutamine dose (mcg∕kg∕ min ) + 100 × epinephrine dose (mcg∕kg∕ min ) + 10 × milrinone dose (mcg∕kg∕ min ) + 10,000 × vasopressin dose (units∕kg∕ min ) + 100 × norepinephrine dose (mcg∕kg∕ min )",{"measure":25,"description":26,"timeFrame":17},"Horowitz index dynamics","Arterial oxygen partial pressure (PaO2)\u002Ffraction of inspired oxygen (FiO2) ratio (Horowitz index) dynamics",{"measure":28,"description":29,"timeFrame":17},"Lactate level dynamics","Lactate level dynamics (mmol\u002Fl)",{"measure":31,"description":32,"timeFrame":17},"Total bilirubin level dynamics","Total bilirubin level dynamics (mcmol\u002Fl)",{"measure":34,"description":35,"timeFrame":36},"Indirect bilirubin level dynamics","Indirect bilirubin level dynamics (mcmol\u002Fl)","Time Frame: Assessed at 4 time points: before hemoadsorption initiation (baseline); 24 hours, 48 hours and 72 hours after hemoadsorption initiation",{"measure":38,"description":39,"timeFrame":36},"Direct bilirubin level dynamics","Direct bilirubin level dynamics (mcmol\u002Fl)",{"measure":41,"description":42,"timeFrame":36},"Ferritin level dynamics","Ferritin level dynamics (mcg\u002Fl)",{"measure":44,"description":45,"timeFrame":36},"Procalcitonin (PCT) level dynamics","Procalcitonin (PCT) level dynamics (ng\u002Fml)",{"measure":47,"description":48,"timeFrame":36},"C- reactive protein (CRP) level dynamics","C- reactive protein (CRP) level dynamics (mg\u002Fl)",{"measure":50,"description":50,"timeFrame":36},"NLR (neutrophil-to-lymphocyte ratio) dynamics",{"measure":52,"description":52,"timeFrame":17},"PLR (Platelet-to-lymphocyte ratio) dynamics",{"measure":54,"description":55,"timeFrame":56},"TNF (Tumor necrosis factor-alpha) level dynamics","TNF (Tumor necrosis factor-alpha) level dynamics (pg\u002Fml)","Assessed at 3 time points: before hemoadsorption initiation (baseline); 48 hours and 72 hours after hemoadsorption initiation",{"measure":58,"description":59,"timeFrame":56},"IL 6 (Interleukin 6) level dynamics","IL 6 (Interleukin 6) level dynamics (pg\u002Fml)",{"measure":61,"description":62,"timeFrame":63},"IL 10 (Interleukin 10) level dynamics","IL 10 (Interleukin 10) level dynamics (pg\u002Fml)","Time Frame: Assessed at 3 time points: before hemoadsorption initiation (baseline); 48 hours and 72 hours after hemoadsorption initiation",{"measure":65,"description":65,"timeFrame":66},"28 - days mortality","Will be calculated for 28 days after hemoadsorption initiation",{"measure":68,"description":68,"timeFrame":69},"90 - days mortality","Will be calculated for 90 days after hemoadsorption initiation",{"measure":71,"description":72,"timeFrame":73},"SOFA (sequential organ failure assessment) dynamics","MODS (multiple organ disfunction syndrome) dynamics majored by SOFA (sequential organ failure assessment) score","Assessed at 4 time points: before hemoadsorption initiatioin (baseline); at 24, 48 and 120 hours after hemoadsorption initiation",{"measure":75,"description":76,"timeFrame":77},"SOFA 2 (sequential organ failure assessment) dynamics","MODS (multiple organ disfunction syndrome) dynamics majored by SOFA 2 (sequential organ failure assessment) score","Assessed at 5 time points: before hemoadsorption initiatioin (baseline); at 24, 48, 72 and 120 hours after hemoadsorption initiation",[79,81,83,85,87,89],{"measure":80,"description":80,"timeFrame":66},"Ventilator-free days",{"measure":82,"description":82,"timeFrame":66},"Vasopressor-free days",{"measure":84,"description":84,"timeFrame":66},"Dialysis-free days",{"measure":86,"description":86,"timeFrame":66},"Hospital length of stay",{"measure":88,"description":88,"timeFrame":66},"Intensive care unit (ICU) length of stay",{"measure":90,"description":91,"timeFrame":92},"AEs (adverse events)","The safety will be assessed by analysing the number of adverse events (AEs) where causal relationship with the intervention cannot be excluded, up until Day 28.","Serious AEs will be reported up to Day 28",{"allocation":94,"interventionModel":95,"interventionModelDescription":96,"primaryPurpose":97,"observationalModel":98,"timePerspective":98,"maskingInfo":99},"RANDOMIZED","PARALLEL","Prospective, pilot, multicenter, parallel-group randomized controlled trial. Participants are independently stratified into 2 parallel groups based on the Endotoxin activity Assay (EAA) level: Group 1- inflammatory mediatiors adsorption (EAA\\\u003C0.6), group 2- Endotoxin adsorption (EAA 0.6-0.9). Within each distinct group, participants are randomized in a 1:1 ratio to receive either a CytoSorb (subgroup 1)\u002FJafron HA 330 (subgroup 2) in group 1 or Toramyxin PMX 20R (subgroup 3)\u002FEfferon LPS (subgroup 4) in group 2.\n\nEvery patient will receive 2 procedures of hemoadsorption","TREATMENT",null,{"masking":100,"maskingDescription":101,"whoMasked":102},"DOUBLE","Double (Investigator, Outcomes Assessor)",[103,104],"INVESTIGATOR","OUTCOMES_ASSESSOR","Every participant will receive 2 adsorption procedures. The second procedure will be initiated no later than 24 hours after the initiation of the first procedure.\n\nLPS adsorption will be performed in 38 participants (Efferon LPS in 19 participants and Toramyxin in 19 participants), two procedures per participant.\n\nInflammatory mediator adsorption will be performed in 38 participants (Jafron HA 330 in 19 participants and CytoSorb in 19 participants), two procedures per participant.\n\nSample size calculations were performed separately for each treatment cohort. For the endotoxemia cohort (EAA level of 0.6-0.9), this randomized trial is designed to compare Efferron LPS and Toraymyxin with respect to change in SOFA score at 72 hours.\n\nAt present, no universally accepted minimal clinically important difference (MCID) has been established for the SOFA score in participants with septic shock. Therefore, the assumed treatment effect was derived from published evidence and expert clinical judgment.\n\nIn the EUPHAS trial, polymyxin B hemoperfusion was associated with a mean reduction in SOFA score of approximately 3.4 points at 72 hours, whereas minimal change was observed in the control group. Similarly, the LASSO study demonstrated substantial improvement in organ dysfunction following endotoxin adsorption therapy.\n\nFor the inflammatory mediator adsorption cohort (EAA level less than 0.6), this randomized trial is designed to compare CytoSorb and Jafron HA 330 with respect to change in SOFA score at 72 hours.\n\nIn the retrospective study Mehta et al., CytoSorb hemoperfusion was associated with a mean reduction in SOFA score of approximately 2.0 points after treatment in survival group. Similarly, the case series Onuk et al. demonstrated substantial improvement in organ dysfunction following inflammatory adsorption therapy with Jafron HA 330 with a mean reduction in SOFA score of approximately 3.5 points at 72 hours.\n\nA between-group difference of 2.5 SOFA points was considered clinically meaningful for both Endotoxin hemoadsorption and inflammatory mediators hemoadsorption because it represents a substantial proportion of the treatment effect observed in previous hemoperfusion studies and corresponds to a clinically relevant difference in the degree of organ dysfunction improvement.\n\nThe sample size for both groups (LPS and inflammatory mediator adsorption) was calculated based on the following assumption: the primary endpoint was the change in SOFA score at 72 hours (ΔSOFA); the expected between-group difference - 2.5 points on the SOFA score; standard deviation of ΔSOFA - 2.5 points; equal allocation ratio (1:1); two-sided significance level (α) of 0.05; statistical power of 80%.\n\nSample size estimation was performed in R using the power.t.test() function. The calculation yielded a required sample size of 16.7 participants per group. Therefore, a minimum of 17 participants per group (34 participants in total) is required to achieve the planned statistical power.\n\nTo account for an anticipated 10% dropout rate, the final sample size will be 19 patients per group (38 participants in total for LPS+ 38 participants in total for Inflammatory mediators adsorption. 76 participants in total).",[107,113,119,124],{"label":108,"type":109,"description":110,"interventionNames":111},"Inflammatory mediatiors adsorption with CytoSorb","EXPERIMENTAL","Inflammatory mediatiors adsorption with EAA \\\u003C0,6 with CytoSorb",[112],"Device: CytoSorb",{"label":114,"type":115,"description":116,"interventionNames":117},"Inflammatory mediatiors adsorption with Jafron HA 330","ACTIVE_COMPARATOR","Inflammatory mediatiors adsorption with EAA \\\u003C0,6 with Jafron HA 330",[118],"Device: Jafron HA 330",{"label":120,"type":109,"description":121,"interventionNames":122},"Endotoxin haemoadsorption with Toramyxin PMX 20R","Endotoxin haemoadsorption with EAA \\[0.6-0.9\\] with Toramyxin PMX 20R",[123],"Device: Toramyxin PMX 20R",{"label":125,"type":115,"description":126,"interventionNames":127},"Endotoxin haemoadsorption with Efferon LPS","Endotoxin haemoadsorption with EAA \\[0.6-0.9\\] with Efferon LPS",[128],"Device: Efferon LPS",[130,135,139,143],{"type":131,"name":132,"description":133,"armGroupLabels":134,"otherNames":98},"DEVICE","Efferon LPS","Blood purification with Efferon LPS",[125],{"type":131,"name":136,"description":137,"armGroupLabels":138,"otherNames":98},"Toramyxin PMX 20R","Blood purification with Toramyxin PMX 20R",[120],{"type":131,"name":140,"description":141,"armGroupLabels":142,"otherNames":98},"Jafron HA 330","Blood purification with Jafron HA 330",[114],{"type":131,"name":144,"description":141,"armGroupLabels":145,"otherNames":98},"CytoSorb",[108],[147],{"name":148,"affiliation":149,"role":150},"Denis Protsenko, MD, PHD","Moscow Multi-disciplinary Clinical Center \"Kommunarka\"","STUDY_DIRECTOR",[152],{"name":153,"role":154,"phone":155,"phoneExt":98,"email":156},"Aleksandr Burov, PHD","CONTACT","+79854215478","Aleksander.bour@mail.ru",[158,174,184,194,198,208,218],{"facility":159,"status":98,"city":160,"state":98,"zip":98,"country":161,"countryCode":162,"cosmosGeoPoint":163,"geoPoint":168,"contacts":169},"Bakulev Scientific Center of Cardiovascular Surgery","Moscow","Russia","RU",{"type":164,"coordinates":165},"Point",[166,167],37.61781,55.75204,{"lat":167,"lon":166},[170],{"name":171,"role":154,"phone":172,"phoneExt":98,"email":173},"Mikhail Yarustovskiy, MD, PHD","+79104194682","mbyar@yandex.ru",{"facility":175,"status":98,"city":160,"state":98,"zip":98,"country":161,"countryCode":162,"cosmosGeoPoint":176,"geoPoint":178,"contacts":179},"City clinical hospital named after S. S. Yudin, Moscow City Health",{"type":164,"coordinates":177},[166,167],{"lat":167,"lon":166},[180],{"name":181,"role":154,"phone":182,"phoneExt":98,"email":183},"Nikolay Krotenko, PHD","+79268664976","npkrotenko@gmail.com",{"facility":185,"status":98,"city":160,"state":98,"zip":98,"country":161,"countryCode":162,"cosmosGeoPoint":186,"geoPoint":188,"contacts":189},"City Clinical Hospital No 52, Moscow, Russia",{"type":164,"coordinates":187},[166,167],{"lat":167,"lon":166},[190],{"name":191,"role":154,"phone":192,"phoneExt":98,"email":193},"Rustam Iskhakov","+79265317813","stamius@yandex.ru",{"facility":149,"status":98,"city":160,"state":98,"zip":98,"country":161,"countryCode":162,"cosmosGeoPoint":195,"geoPoint":197,"contacts":98},{"type":164,"coordinates":196},[166,167],{"lat":167,"lon":166},{"facility":199,"status":98,"city":160,"state":98,"zip":98,"country":161,"countryCode":162,"cosmosGeoPoint":200,"geoPoint":202,"contacts":203},"Petrovsky National Research Centre of Surgery",{"type":164,"coordinates":201},[166,167],{"lat":167,"lon":166},[204],{"name":205,"role":154,"phone":206,"phoneExt":98,"email":207},"Maxim Babaev, MD, PHD","+79160269066","maxbabaev@mail.ru",{"facility":209,"status":98,"city":160,"state":98,"zip":98,"country":161,"countryCode":162,"cosmosGeoPoint":210,"geoPoint":212,"contacts":213},"Sklifosovsky Institute of Emergency Care",{"type":164,"coordinates":211},[166,167],{"lat":167,"lon":166},[214],{"name":215,"role":154,"phone":216,"phoneExt":98,"email":217},"Sergei Rei, PHD","+79166001362","reysi@sklif.mos.ru",{"facility":219,"status":98,"city":220,"state":98,"zip":98,"country":161,"countryCode":162,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"National Medical Research Centre for Oncology Rostov-on-Don","Rostov-on-Don",{"type":164,"coordinates":222},[223,224],39.70769,47.21997,{"lat":224,"lon":223},[227],{"name":228,"role":154,"phone":229,"phoneExt":98,"email":230},"Natalia Ushakova, MD, PHD","+79185533155","ndu2000@rambler.ru",{"type":232,"investigatorFullName":98,"investigatorTitle":98,"investigatorAffiliation":98,"oldNameTitle":98,"oldOrganization":98},"SPONSOR",[234,236,237,238,239,241],{"name":199,"class":235},"OTHER",{"name":159,"class":6},{"name":175,"class":235},{"name":209,"class":6},{"name":185,"class":240},"UNKNOWN",{"name":242,"class":6},"Rostov Regional Clinical Hospital","100641441","hemoadsorpion-in-patients-with-septic-shock-efficacy-and-safety-evaluation-100641441",false,"NCT07661303","Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation","Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation. A Pilot Multicenter Randomized Controlled Trial","HAdSS","Inclusion Criteria:\n\n* Septic shock according to SEPSIS-3 criteria\n* Age: 18-80 years\n* SOFA ≥9 points\n* Diagnosis of septic shock established \\\u003C12 hours ago\n* Invasive hemodynamic monitoring\n* Norepinephrine dose \\>0.2 mcg\u002Fkg\u002Fmin\n\nExclusion Criteria:\n\n* Absolute neutrophil count less than 500 cells\u002FμL\n* Pregnancy\n* End-stage heart failure (NYHA stage IV)\n* Pulmonary embolism with obstructive shock\n* Ongoing bleeding\n* Atonic coma\n* More than 30 points on the MELD scale, class C on the Child-Pugh scale\n* HIV infection\n* Burns over 10% of the body surface area\n* Patients with oncohematological diseases\n* Patients with a recognized palliative status or the definition of \"metastatic cancer\"\n* RRT using membranes with a high cutoff point and increased adsorption capacity within 72 hours from the initiation of the first hemoadsorption procedure\n* Use of plasma exchange within 72 hours from the initiation of the first hemoadsorption procedure","ALL","18 Years","80 Years",{"count":255,"type":256},76,"ESTIMATED","INTERVENTIONAL",[259],"NA","Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation. A Pilot Multicenter Randomized Controlled Trial.\n\nThe goal of this clinical trial is the estimation of the efficacy and safety of hemoadsorption procedures (LPS (Lipopolysaccharide) and inflammatory mediators adsorption) in participants with septic shock.\n\nThe main questions it aims to answer are:\n\nDoes hemoadsorption decrease the severity of MODS (multiple organ disfunction syndrome)?\n\nThe study will include participants aged 18 to 80 years with a verified diagnosis of septic shock according to SEPSIS 3 criteria, diagnosed within 12 hours, and a SOFA (sequential organ failure assessment) score of 9 or more.\n\nIn addition to Standard of Care (SOC), blood purification, including hemoadsorption, will be used. The minimum waiting time after diagnosis of septic shock and initiation of basic therapy before inclusion of the patient in the study therapy is 4 hours.\n\nThe choice of procedure will be based on the EAA (Endotoxin Activity Assay) result:\n\n* for an EAA level of 0.6-0.9, selective lipopolysaccharide (LPS) adsorption with duration from 2 to 10 hours;\n* for an EAA level less than 0.6, inflammatory mediator adsorption with duration from 6 to 12 hours.\n\nThe choice of a specific adsorbers within the LPS and inflammatory mediator adsorption group will be based on randomization.\n\nThe use of LPS adsorption is planned based on randomization: Toramyxin R-20 or Efferon LPS. The use of inflammatory mediator adsorption is planned based on randomization: Jafron (HA 330) or CytoSorb.",[262],"Septic Shock",[264,265,266,267,268],"Septic shock","hemoadsorption","blood purification","MODS","Endotoxemia","NOT_YET_RECRUITING","2026-06-30",{"date":272,"type":273},"2026-07-02","ACTUAL",{"date":275,"type":256},"2026-06-25",{"date":277,"type":256},"2027-12-25",{"name":5,"class":6},7]