[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100469954":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":27,"locations":33,"responsibleParty":227,"collaborators":229,"id":232,"slug":233,"hasResults":234,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":21,"eligibilityCriteria":238,"healthyVolunteers":234,"sex":239,"minAge":240,"maxAge":21,"enrollmentInfo":241,"targetDuration":21,"studyType":244,"phases":245,"briefSummary":247,"conditions":248,"keywords":21,"overallStatus":36,"whyStopped":21,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":261},{"fullName":5,"class":6},"Vantive Health LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Prismocitrate 18 using the PrisMax System Version 3.x with calcium line accessory","EXPERIMENTAL","This is a single-arm study. Patients will receive regional citrate anticoagulation (RCA) with Prismocitrate 18 (investigational drug) during their CRRT treatment using the PrisMax System Version 3.x with calcium line accessory (investigational device).",[13,14],"Drug: Prismocitrate 18","Device: PrisMax System Version 3.x with calcium line accessory",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Prismocitrate 18","Prismocitrate 18 solution (investigational drug) will be used in pre-dilution mode only; the rate of administration depends on the targeted citrate dose and the prescribed flow rate. The pre-filter infusion rate of Prismocitrate 18 solution will be indexed to the blood flow rate (BFR) to achieve a target blood citrate concentration of 3 mmol\u002FL of blood. The flow rate for the anticoagulation of the extracorporeal circuit will be titrated to achieve a post-filter concentration of iCa of 0.25 to 0.35 mmol\u002FL.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DEVICE","PrisMax System Version 3.x with calcium line accessory","The RCA software on PrisMax System Version 3.x with calcium line accessory (investigational device) will be enabled to carefully guide the health practitioner for citrate dosing and calcium compensation.",[9],[28],{"name":29,"role":30,"phone":31,"phoneExt":21,"email":32},"Global CORP Clinical Trials Disclosure","CONTACT","+1 2249484283","Global.CORP.ClinicalTrialsDisclosure@vantive.com",[34,52,71,78,92,105,118,135,151,160,170,186,202,218],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"University of Alabama at Birmingham\u002FUAB","RECRUITING","Birmingham","Alabama","35294-0007","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-86.80249,33.52066,{"lat":46,"lon":45},[49],{"name":50,"role":51,"phone":21,"phoneExt":21,"email":21},"Eric Judd, MD","PRINCIPAL_INVESTIGATOR",{"facility":53,"status":36,"city":54,"state":55,"zip":56,"country":40,"countryCode":41,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"University of Southern California (USC) \u002F Keck Hospital","Los Angeles","California","90033",{"type":43,"coordinates":58},[59,60],-118.24368,34.05223,{"lat":60,"lon":59},[63,66,69],{"name":64,"role":30,"phone":21,"phoneExt":21,"email":65},"Gina Kucherepa","Gina.kucherepa@med.usc.edu",{"name":67,"role":30,"phone":21,"phoneExt":21,"email":68},"Carolina Unizony","carolina.unizony@med.usc.edu",{"name":70,"role":51,"phone":21,"phoneExt":21,"email":21},"Fadi Tohme, MD",{"facility":72,"status":73,"city":54,"state":55,"zip":74,"country":40,"countryCode":41,"cosmosGeoPoint":75,"geoPoint":77,"contacts":21},"University of California Los Angeles","WITHDRAWN","90095",{"type":43,"coordinates":76},[59,60],{"lat":60,"lon":59},{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":40,"countryCode":41,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"University of Miami","NOT_YET_RECRUITING","Miami","Florida","33136",{"type":43,"coordinates":85},[86,87],-80.19366,25.77427,{"lat":87,"lon":86},[90],{"name":91,"role":51,"phone":21,"phoneExt":21,"email":21},"Juan Duque, MD",{"facility":93,"status":36,"city":94,"state":95,"zip":96,"country":40,"countryCode":41,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Emory University","Atlanta","Georgia","30322",{"type":43,"coordinates":98},[99,100],-84.38798,33.749,{"lat":100,"lon":99},[103],{"name":104,"role":51,"phone":21,"phoneExt":21,"email":21},"Michael J Connor Jr., MD",{"facility":106,"status":80,"city":107,"state":108,"zip":109,"country":40,"countryCode":41,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"University of Michigan","Ann Arbor","Michigan","48109",{"type":43,"coordinates":111},[112,113],-83.74088,42.27756,{"lat":113,"lon":112},[116],{"name":117,"role":51,"phone":21,"phoneExt":21,"email":21},"Lenar Yessayan, MD",{"facility":119,"status":36,"city":120,"state":121,"zip":122,"country":40,"countryCode":41,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Bon Secours Mercy Health-Springfield Regional Medical Center","Springfield","Ohio","45504",{"type":43,"coordinates":124},[125,126],-83.80882,39.92423,{"lat":126,"lon":125},[129,133],{"name":130,"role":30,"phone":131,"phoneExt":21,"email":132},"Katrina Reynolds","937-523-5300","KReynolds@mercy.com",{"name":134,"role":51,"phone":21,"phoneExt":21,"email":21},"Sanju Varghese, MD",{"facility":136,"status":80,"city":137,"state":138,"zip":139,"country":40,"countryCode":41,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Geisinger Medical Center","Danville","Pennsylvania","17822",{"type":43,"coordinates":141},[142,143],-76.61273,40.96342,{"lat":143,"lon":142},[146,149],{"name":147,"role":30,"phone":21,"phoneExt":21,"email":148},"Natacha A Morris","nmantunesmorris@geisinger.edu",{"name":150,"role":51,"phone":21,"phoneExt":21,"email":21},"Maria C Bermudez, MD",{"facility":152,"status":73,"city":153,"state":138,"zip":154,"country":40,"countryCode":41,"cosmosGeoPoint":155,"geoPoint":159,"contacts":21},"Penn State Hershey Medical Center","Hershey","17033",{"type":43,"coordinates":156},[157,158],-76.65025,40.28592,{"lat":158,"lon":157},{"facility":161,"status":162,"city":163,"state":138,"zip":164,"country":40,"countryCode":41,"cosmosGeoPoint":165,"geoPoint":169,"contacts":21},"VA Pittsburgh Healthcare System","ACTIVE_NOT_RECRUITING","Pittsburgh","15240",{"type":43,"coordinates":166},[167,168],-79.99589,40.44062,{"lat":168,"lon":167},{"facility":171,"status":80,"city":172,"state":173,"zip":174,"country":40,"countryCode":41,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Medical University of South Carolina (MUSC)","Charleston","South Carolina","29425",{"type":43,"coordinates":176},[177,178],-79.93275,32.77632,{"lat":178,"lon":177},[181,184],{"name":182,"role":30,"phone":21,"phoneExt":21,"email":183},"Angela Francisco","millare@musc.edu",{"name":185,"role":51,"phone":21,"phoneExt":21,"email":21},"Blaithin McMahon, MD",{"facility":187,"status":36,"city":188,"state":189,"zip":190,"country":40,"countryCode":41,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Lt. Col. Luke Weathers, Jr. VA Medical Center","Memphis","Tennessee","38104",{"type":43,"coordinates":192},[193,194],-90.04898,35.14953,{"lat":194,"lon":193},[197,200],{"name":198,"role":30,"phone":21,"phoneExt":21,"email":199},"Lillie Johnson","Lillie.johnson3@va.gov",{"name":201,"role":51,"phone":21,"phoneExt":21,"email":21},"Geeta Gyamlani, MD",{"facility":203,"status":80,"city":204,"state":205,"zip":206,"country":40,"countryCode":41,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Methodist Dallas Medical Center","Dallas","Texas","75203",{"type":43,"coordinates":208},[209,210],-96.80667,32.78306,{"lat":210,"lon":209},[213,216],{"name":214,"role":30,"phone":21,"phoneExt":21,"email":215},"Sophie He","SophieHe@mhd.com",{"name":217,"role":51,"phone":21,"phoneExt":21,"email":21},"Roberto Collazo-Maldonado, MD",{"facility":219,"status":162,"city":220,"state":205,"zip":221,"country":40,"countryCode":41,"cosmosGeoPoint":222,"geoPoint":226,"contacts":21},"Gamma Medical Research, Inc \u002F McAllen Medical Center","McAllen","78503",{"type":43,"coordinates":223},[224,225],-98.23001,26.20341,{"lat":225,"lon":224},{"type":228,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[230],{"name":231,"class":6},"Baxter Healthcare Corporation","100469954","phase-3-safety-evaluation-of-prismocitrate-18-in-patients-receiving-crrt-100469954",false,"NCT05399537","Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT","A Safety Evaluation of Prismocitrate 18 in Patients Receiving Continuous Renal Replacement Therapy (CRRT)","Inclusion Criteria:\n\n* Patients must be ≥18 years of age\n* Patients who are candidates for CRRT\n* Patients expected to survive for at least 24 hours\n* Patients with a contraindication to heparin or an increased risk of hemorrhage\n* Patient and\u002For legally-authorized representative has signed a written informed consent form (ICF) per 21 CFR Part 50.55(e)\n\nExclusion Criteria:\n\n* Patients with a known allergy to citrate or who have ever experienced an adverse reaction associated with citrate products, including patients with a prior history of citrate toxicity\n* Patients with acute liver failure, defined by the occurrence of encephalopathy and hepatic synthetic dysfunction within 26 weeks of the first symptoms of liver disease and without evidence of chronic liver disease\n* Patients with acute-on-chronic liver failure characterized by acute decompensation of cirrhosis and a Child-Pugh Liver Failure Score \\>10\n* Patients with refractory shock and associated lactic acidosis (lactate \\>4 mmol\u002FL)\n* Patients with a systemic ionized calcium concentration outside the normal physiologic range (1.0 - 1.3 mmol\u002FL), or outside of the laboratory reference range (Note: It is acceptable to provide calcium supplementation or treatment for hypercalcemia to achieve a normal physiologic range prior to therapy initiation)\n* Female patients of childbearing potential who are pregnant or breastfeeding. (Note: All female patients, who have not undergone a hysterectomy, bilateral oophorectomy with or without hysterectomy, or has medically documented ovarian failure before study Screening must have a negative serum beta human chorionic gonadotropic \\[B-hCG\\] pregnancy test at Screening)\n* Patients who are currently participating in another interventional clinical study","ALL","18 Years",{"count":242,"type":243},40,"ESTIMATED","INTERVENTIONAL",[246],"PHASE3","Prismocitrate 18 is a continuous renal replacement therapy (CRRT) solution to be used as a renal replacement solution and as an anticoagulant to prevent blood clotting in the extracorporeal circuit. The delivery of CRRT therapy is provided by the PrisMax System which includes regional citrate anticoagulation (RCA) software to facilitate citrate and calcium compensation prescription.\n\nThe objectives of this study are: 1) to confirm the safety of Prismocitrate 18 in patients receiving CRRT using continuous venovenous hemodiafiltration (CVVHDF) or continuous venovenous hemofiltration (CVVH) and 2) to observe that the software and interface for the PrisMax System Version 3.x with calcium line accessory allows for implementation of regional citrate anticoagulation (RCA) (citrate and calcium dosing) during CRRT with Prismocitrate 18 and intended prescription.\n\nThe study period of the patient's CRRT will be up to 10 days.",[249,250,251],"Regional Citrate Anticoagulation (RCA)","Continuous Renal Replacement Therapy (CRRT)","Acute Kidney Injury (AKI)","2026-04-10",{"date":254,"type":255},"2026-04-13","ACTUAL",{"date":257,"type":255},"2024-07-12",{"date":259,"type":243},"2026-12",{"name":5,"class":6},14]