[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625220":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":30,"responsibleParty":46,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":10,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":72,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Pauls Stradins Clinical University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Oxiris CVVH Septic Shock Cohort",null,"Adult patients with septic shock admitted to the intensive care unit and treated with continuous veno-venous hemofiltration (CVVH) using the Oxiris® hemofilter as part of standard-of-care therapy. All participants receive the same CRRT modality; no comparator or control group is included. The cohort is used to evaluate time-dependent endotoxin and cytokine removal, membrane adsorption performance, and cytokine convective clearance during a 24-hour Oxiris® treatment period.",[13],"Device: AN69-polyethylenimine hemofilter (Oxiris®) used for continuous veno-venous hemofiltration (CVVH)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","AN69-polyethylenimine hemofilter (Oxiris®) used for continuous veno-venous hemofiltration (CVVH)","Continuous veno-venous hemofiltration (CVVH) performed using the AN69-polyethylenimine (Oxiris®) hemofilter as part of standard-of-care treatment in adult patients with septic shock. The Oxiris® membrane is a high-adsorptive, polyethyleneimine-coated AN69 filter designed for simultaneous renal replacement therapy and removal of circulating endotoxins and inflammatory mediators. CVVH is delivered using standardized clinical settings, including blood flow 100-150 mL\u002Fmin, filtration dose 25-30 mL\u002Fkg\u002Fh, regional citrate anticoagulation, and a 24-hour treatment period with serial blood and effluent sampling to assess membrane adsorption and convective clearance.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Darja Smirnova, MD","CONTACT","+37126359852","darja.smirnova@rsu.lv",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Olegs Sabelnikovs, Prof","+37129561827","olegs.sabelnikovs@stradini.lv",[31],{"facility":32,"status":33,"city":34,"state":10,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Pauls Stradiņš Clinical University Hospital, Department of Anesthesiology and Reanimatology","RECRUITING","Riga","LV1002","Latvia","LV",{"type":39,"coordinates":40},"Point",[41,42],24.10589,56.946,{"lat":42,"lon":41},[45],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[49],{"name":50,"class":51},"Vantive Health LLC","INDUSTRY","100625220","oxiclear-oxiris-cytokines-and-endotoxin-adsorption-rate-study-100625220",false,"NCT07419802","OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study","Endotoxin and Cytokine Adsorption Properties of the Oxiris Hemofilter in Septic Shock: Evaluation of Saturation Phenomena and Inflammatory Mediators' Clearance Capacity","OxiCLEAR","Inclusion Criteria (should meet all the criteria mentioned below):\n\n* Septic shock patient with a Dynamic scoring system of 6-8 points \u002FSeptic shock definition based on Sepsis-3: a vasopressor requirement to maintain a mean arterial pressure of 65 mmHg or greater and serum lactate greater than 2mmol\u002FL despite optimal (30ml\u002Fkg body weight) bolus fluid resuscitation\u002F\n* CVVH with AN69-polyethylenimine (Oxiris) membrane for at least 24 hours\n* Age \\>18 years\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnancy\n* Known contraindications to citrate anticoagulation\n* High likelihood of death within 24 hours due to irreversible comorbidities (e.g., end-stage cardiac, pulmonary, or hepatic disease; hepatorenal syndrome; advanced uncontrolled malignancy)\n* Simultaneous treatment with another adsorption device during the study period","ALL","18 Years",{"count":63,"type":64},29,"ESTIMATED","OBSERVATIONAL","This study examines how well the Oxiris® hemofilter works over time in adults with septic shock who require continuous kidney support in the intensive care unit (ICU).\n\nSeptic shock is a severe form of infection that leads to organ failure, including acute kidney injury. Many people with septic shock require continuous renal replacement therapy (CRRT), a form of dialysis that runs continuously to support the kidneys. The Oxiris® hemofilter is a special type of CRRT filter designed not only to replace kidney function but also to remove harmful substances from the blood, including endotoxins from bacteria and inflammatory proteins (cytokines).\n\nAlthough Oxiris® is widely used, it is not known how long the filter continues to remove these substances effectively. Over time, the membrane of the filter may become filled with endotoxins and cytokines, which could reduce its ability to clean the blood. This study aims to determine whether and when this loss of adsorption occurs during a standard twenty-four-hour treatment period.\n\nAdults with septic shock who receive Oxiris® as part of routine ICU care will take part in this observational study. No experimental treatment will be given. Blood samples will be taken before and after the filter, and fluid leaving the filter will be collected, to measure how endotoxins and cytokines are removed over time.\n\nThe study will also assess how changes in filter performance relate to clinical markers such as blood pressure support, blood lactate levels, organ function scores, kidney recovery, and twenty-eight-day survival.\n\nThe results will help define the optimal timing for Oxiris® filter replacement and support more effective use of blood purification therapy in patients with septic shock.",[68,69,70,71],"Sepsis","Septic Shock","Blood Purification","Hemoadsorption",[73,74,75,76,77,78,79,80,81,82,83,84,85,86,87],"Oxiris","blood purification","hemoadsorption","septic shock","saturation phenomena","Continuous renal replacement therapy (CRRT)","AN69-polyethylenimine membrane","Endotoxin adsorption","Cytokine adsorption","Membrane saturation","Mass balance","Inlet-outlet concentration gradient","Membrane fouling","Precision blood purification","Endotoxemia","2026-02-16",{"date":90,"type":91},"2026-02-19","ACTUAL",{"date":93,"type":64},"2026-03-01",{"date":95,"type":64},"2027-09-01",{"name":5,"class":6},1]