[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574065":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":42,"collaborators":20,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":20,"eligibilityCriteria":51,"healthyVolunteers":48,"sex":52,"minAge":53,"maxAge":20,"enrollmentInfo":54,"targetDuration":20,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":20,"overallStatus":64,"whyStopped":20,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Beijing Anzhen Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"L-AmB group","EXPERIMENTAL","To establish and validate a population pharmacokinetic model for L-AmB in patients with severe invasive fungal infections treated undergoing ECMO-assisted therapy.",[13],"Biological: Determination of blood drug concentration",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Determination of blood drug concentration","Collecting blood samples from patients and determining blood drug concentrations. Patients were intravenously titrated after 3 doses of maintenance dose titration of L-AmB. The time points of sample collecting were 30 minutes before and 1, 2, 3, 6, 9, 12, 16, 20, 24 hours after administration. Then, the blood concentrations were determined according to the established method.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Yang Lin, PhD","CONTACT","86-010-64456609","linyang3623@outlook.com",[28],{"facility":5,"status":20,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Beijing","Beijing Municipality","100029","China","CN",{"type":35,"coordinates":36},"Point",[37,38],116.39723,39.9075,{"lat":38,"lon":37},[41],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Lin Yang","Director of pharmacy department of Beijing Anzhen Hospital","100574065","phase-4-population-pharmacokinetics-of-l-amb-in-chinese-patients-assisted-by-extracorporeal-membrane-pulmonary-oxygenation-ecmo-100574065",false,"NCT06754436","Population Pharmacokinetics of L-AmB in Chinese Patients Assisted by Extracorporeal Membrane Pulmonary Oxygenation (ECMO)","Inclusion Criteria:\n\n* Diagnostic criteria for invasive fungal infections presenting to the intensive care unit (ICU) with probable or proved patients According to the 2021 EORTC\u002FMSGERC guideline.\n* Requiring ECOM assistance.\n* Age 18 years.\n\nExclusion Criteria:\n\n* Intolerance of L-AmB therapy.\n* Pregnancy.\n* Expected survival time \\\u003C24 hours.\n* Lack of necessary data on patient demographics physiopathology, and clinical status.","ALL","18 Years",{"count":55,"type":56},30,"ESTIMATED","INTERVENTIONAL",[59],"PHASE4","The goal of this study is to investigate the effects of ECMO-assisted therapy on L-AmB PK parameters in patients with critically ill patients of invasive fungal infections, and to determine the in vivo pharmacokinetic changes of L-AmB in the ECMO population. To establish and validate a population pharmacokinetic model for liposomal amphotericin B in patients with critically ill patients of invasive fungal infections treated with ECMO adjuvant therapy, and to explore the pharmacokinetics\u002Fpharmacodynamics of the drug with different dosing regimens.",[62,63],"Invasive Fungal Infections","Liposomal Amphotericin B","NOT_YET_RECRUITING","2024-12-30",{"date":67,"type":68},"2024-12-31","ACTUAL",{"date":70,"type":56},"2025-01-10",{"date":72,"type":56},"2026-02-01",{"name":5,"class":6},1]