[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618022":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":17,"centralContacts":31,"locations":37,"responsibleParty":169,"collaborators":17,"id":171,"slug":172,"hasResults":173,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":17,"eligibilityCriteria":177,"healthyVolunteers":173,"sex":178,"minAge":179,"maxAge":17,"enrollmentInfo":180,"targetDuration":17,"studyType":183,"phases":184,"briefSummary":186,"conditions":187,"keywords":17,"overallStatus":122,"whyStopped":17,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},{"fullName":5,"class":6},"Vantive Health LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients receiving IMV combined with ECCO2R","EXPERIMENTAL","Patients will receive IMV combined with ECCO2R using PrismaLung+.",[13],"Device: PrismaLung+",{"label":15,"type":16,"description":17,"interventionNames":18},"Patients receiving IMV alone","ACTIVE_COMPARATOR",null,[19],"Other: Invasive Mechanical Ventilation",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":17},"DEVICE","PrismaLung+","PrismaLung+ is a medical device that provides ECCO2R as a stand-alone therapy or in combination with CRRT. The planned treatment duration with PrismaLung+ for patients in the study group is 7 days. However, the Investigator can discontinue PrismaLung+ treatment before 7 days if ECCO2R is no longer required. Following the 7-day treatment period, the Investigator will assess the patient's condition to determine whether to continue ECCO2R. Patients will require systemic anticoagulation with heparin during ECCO2R treatment.\n\nContinuous renal replacement therapy may be administered concurrently to patients during the study, if needed, at the discretion of the Investigator. During the study, patients will be given active treatment for their primary disease.",[9],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":17},"OTHER","Invasive Mechanical Ventilation","According to the standard clinical practice of IMV, oral or nasal endotracheal intubation can be used for IMV. The initial mode of IMV and ventilatory parameters will be determined based on the patient's condition, and an appropriate patient-centered LPV approach will be selected to adjust the ventilatory parameters to achieve the study LPV strategy. Appropriate treatments other than ECCO2R will be provided for this group. Continuous renal replacement therapy may be administered concurrently to patients during the study, if needed, at the discretion of the Investigator. During the study, patients will be given active treatment for their primary disease.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":17,"email":36},"Global CORP Clinical Trials Disclosure","CONTACT","+1 2249484283","Global.CORP.ClinicalTrialsDisclosure@vantive.com",[38,56,69,81,94,107,120,134,147,160],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"China-Japan Friendship Hospital","NOT_YET_RECRUITING","Beijing","Beijing Municipality","100029","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},[53],{"name":54,"role":55,"phone":17,"phoneExt":17,"email":17},"Jun Duan","PRINCIPAL_INVESTIGATOR",{"facility":57,"status":40,"city":58,"state":59,"zip":60,"country":44,"countryCode":45,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"The First Affiliated Hospital of Guangzhou Medical University","Guangzhou","Guangdong","510630",{"type":47,"coordinates":62},[63,64],113.25,23.11667,{"lat":64,"lon":63},[67],{"name":68,"role":55,"phone":17,"phoneExt":17,"email":17},"Ling Sang",{"facility":70,"status":40,"city":71,"state":59,"zip":72,"country":44,"countryCode":45,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"The University of Hong Kong-Shenzhen Hospital","Shenzhen","518053",{"type":47,"coordinates":74},[75,76],114.0683,22.54554,{"lat":76,"lon":75},[79],{"name":80,"role":55,"phone":17,"phoneExt":17,"email":17},"Jun Jin",{"facility":82,"status":40,"city":83,"state":84,"zip":85,"country":44,"countryCode":45,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"The First Affiliated Hospital of Harbin Medical University","Harbin","Heilongjiang","150001",{"type":47,"coordinates":87},[88,89],126.65,45.75,{"lat":89,"lon":88},[92],{"name":93,"role":55,"phone":17,"phoneExt":17,"email":17},"Mingyan Zhao",{"facility":95,"status":40,"city":96,"state":97,"zip":98,"country":44,"countryCode":45,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Zhongda Hospital Southeast University","Nanjing","Jiangsu","210009",{"type":47,"coordinates":100},[101,102],118.77778,32.06167,{"lat":102,"lon":101},[105],{"name":106,"role":55,"phone":17,"phoneExt":17,"email":17},"Ling Liu",{"facility":108,"status":40,"city":109,"state":110,"zip":111,"country":44,"countryCode":45,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"The First Affiliated Hospital of Nanchang University","Nanchang","Jiangxi","330006",{"type":47,"coordinates":113},[114,115],115.85306,28.68396,{"lat":115,"lon":114},[118],{"name":119,"role":55,"phone":17,"phoneExt":17,"email":17},"Zhenguo Zeng",{"facility":121,"status":122,"city":123,"state":124,"zip":125,"country":44,"countryCode":45,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"ZhongShan Hospital Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200032",{"type":47,"coordinates":127},[128,129],121.45806,31.22222,{"lat":129,"lon":128},[132],{"name":133,"role":55,"phone":17,"phoneExt":17,"email":17},"Ming Zhong",{"facility":135,"status":40,"city":136,"state":137,"zip":138,"country":44,"countryCode":45,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Sichuan Provincial People's Hospital","Chengdu","Sichuan","610072",{"type":47,"coordinates":140},[141,142],104.06667,30.66667,{"lat":142,"lon":141},[145],{"name":146,"role":55,"phone":17,"phoneExt":17,"email":17},"Chun Pan",{"facility":148,"status":40,"city":149,"state":150,"zip":151,"country":44,"countryCode":45,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"The First Affiliated Hospital Zhejiang University School of Medicine","Hangzhou","Zhejiang","310003",{"type":47,"coordinates":153},[154,155],120.16142,30.29365,{"lat":155,"lon":154},[158],{"name":159,"role":55,"phone":17,"phoneExt":17,"email":17},"Xia Zheng",{"facility":161,"status":40,"city":149,"state":150,"zip":162,"country":44,"countryCode":45,"cosmosGeoPoint":163,"geoPoint":165,"contacts":166},"Sir Run Run Shaw Hospital Zhejiang University School of Medicine","310016",{"type":47,"coordinates":164},[154,155],{"lat":155,"lon":154},[167],{"name":168,"role":55,"phone":17,"phoneExt":17,"email":17},"Feng Guo",{"type":170,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100618022","a-study-of-the-efficacy-and-safety-of-extracorporeal-carbon-dioxide-removal-using-prismalung-100618022",false,"NCT07326215","A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+","A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+ in Chinese Critically Ill Patients: a Prospective Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Invasive mechanical ventilation patients with PaCO2 \\> 50 mmHg and pH \\\u003C 7.4 under LPV strategy (RR \\\u003C 25\u002Fmin, DP \\\u003C 15 cmH2O).\n3. Expected to be able to tolerate ECCO2R for a minimum of 2h.\n4. Patients signed a written informed consent; if the right to consent cannot be exercised due to loss of decision-making ability or impairment of consciousness, the legal representative or immediate family member must sign the informed consent document after fully understanding the research content.\n\nExclusion Criteria:\n\n1. Body weight \\\u003C 30 kg.\n2. Has a contraindication for systemic anticoagulation with heparin according to the Investigator.\n3. Patient unable to establish extracorporeal circulation access or has a high risk of establishing such access, as judged by the Investigator.\n4. Allergic to the investigational device\u002Ftubing, and\u002For to the CRRT filters\u002Ftubing if combined with CRRT treatment.\n5. Expected to require extracorporeal membrane oxygenator (ECMO) treatment within 24h after enrollment.\n6. Patient's primary disease is expected to worsen rapidly or require other surgical intervention within 24h after enrollment.\n7. Diagnosed as brain dead or in a vegetative state.\n8. Pregnant and\u002For breastfeeding.\n9. Plans to participate in other device studies within 30 days before screening or during the study period or has completed any clinical drug study within 5 half lives of the investigational drug.\n10. Patients is considered as unsuitable for participating in the study, as judged by the Investigator.","ALL","18 Years",{"count":181,"type":182},99,"ESTIMATED","INTERVENTIONAL",[185],"NA","PrismaLung+ is a sterile, single-use medical device aimed at performing partial removal of carbon dioxide (CO2) from the patient's venous blood via diffusion through a membrane. The goal of this prospective, open label, randomized controlled study is to evaluate the efficacy and safety of PrismaLung+ on extracorporeal carbon dioxide removal (ECCO2R) in critically ill patients under invasive mechanical ventilation (IMV). Patients will be randomized to receive either IMV combined with ECCO2R (using PrismaLung+) in the study group or IMV alone in the control group, at a ratio of 2:1.",[188,189],"Acute Respiratory Distress Syndrome","Acute Kidney Injury","2026-02-12",{"date":192,"type":193},"2026-02-17","ACTUAL",{"date":195,"type":193},"2025-12-11",{"date":197,"type":182},"2026-08-31",{"name":5,"class":6},10]