[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fresenius Medical Care North America\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100465317","phase-3-safety-of-regional-citrate-anticoagulation-sarca-study-100465317",false,"NCT05339139","SAfety of Regional Citrate Anticoagulation (SARCA Study)","An Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO System in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study)","SARCA","Inclusion Criteria:\n\n1. Signed informed consent form by\n\n   * The subject or\n   * A legally authorized representative (LAR), if the subject is unable to consent\n2. Adult patients ≥ 18 years old\n3. Diagnosis of AKI or End-Stage Kidney Disease (ESKD) requiring CRRT\n4. Vascular access - Dialysis Catheter with size and location per institutional practice\n\nExclusion Criteria:\n\n1. Metabolic alkalosis as defined by serum bicarbonate greater than 30 mmol\u002FL and arterial pH greater than 7.55\n2. A female who is pregnant or breast feeding\n3. Severe liver disease defined as International Normalized Ratio (INR) greater than 2.0 and total bilirubin greater than 5 mg\u002Fdl, and both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than 3 times upper limit of normal\n4. Subjects currently enrolled in or who have completed any other investigational drug or device study within last 30 days prior to signing informed consent\n5. Previous participation in a similar or the same study.\n6. Subjects already on continuous renal replacement therapy\n7. Subjects with active COVID-19 infection\n8. Subjects cannot tolerate citrate therapy defined as severe liver disease (see exclusion criteria #3), shock with muscle hypoperfusion and known hypersensitivity to citrate","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is an Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO system in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study).",[27,28],"Acute Kidney Injury","ESRD","RECRUITING","2025-04-23",{"date":32,"type":33},"2025-04-24","ACTUAL",{"date":35,"type":33},"2023-10-17",{"date":37,"type":21},"2025-07-31",{"name":39,"class":40},"Fresenius Medical Care North America","INDUSTRY",10,""]