[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495103":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":34,"locations":42,"responsibleParty":331,"collaborators":18,"id":333,"slug":334,"hasResults":335,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":335,"sex":341,"minAge":342,"maxAge":343,"enrollmentInfo":344,"targetDuration":18,"studyType":347,"phases":348,"briefSummary":350,"conditions":351,"keywords":353,"overallStatus":94,"whyStopped":18,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":367},{"fullName":5,"class":6},"Hannover Medical School","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Therapeutic Plasma Exchange (TPE)","EXPERIMENTAL","1 x TPE with donor Fresh Frozen Plasma (FFPs) (1.2 x individual plasma volume) within the first 6 hrs after randomization.\n\nA second TPE can be performed if the patient remains vasopressor dependent ≥ 0.4 ug\u002Fkg\u002Fmin within 24 hours after the first intervention.",[13],"Device: Therapeutic Plasma Exchange (TPE)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care (SOC)","NO_INTERVENTION","Non-interventional standard of care",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DEVICE","The TPE treatment will be initiated within 6 hrs after randomization. Duration of TPE treatment is approximately 120-180 minutes. An additional second TPE can be performed if the patient remains vasopressor dependent ≥ 0.4 ug\u002Fkg\u002Fmin after 24 hours following the first TPE procedure.\n\nBoth unfractionated heparin (UFH) and citrate may be used as anticoagulant medication.\n\nTo ensure treatment comparability between different patients, we will replace plasma in a fixed ratio of 1.2 x the individual patient's total plasma fluid.",[9],[25,29,31],{"name":26,"affiliation":27,"role":28},"Sascha David, Prof. Dr.","University of Zurich","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":5,"role":28},"Klaus Stahl, PD Dr.",{"name":32,"affiliation":33,"role":28},"Christian Bode, PD Dr.","University Hospital, Bonn",[35,39],{"name":26,"role":36,"phone":37,"phoneExt":18,"email":38},"CONTACT","+41 44 255 8653","sascha.david@usz.ch",{"name":30,"role":36,"phone":40,"phoneExt":18,"email":41},"+49 (0)176 1532 8277","stahl.klaus@mh-hannover.de",[43,58,69,83,92,106,117,129,141,150,162,174,183,194,207,214,227,239,251,263,275,283,295,307,320],{"facility":44,"status":45,"city":46,"state":18,"zip":18,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University Hospital Innsbruck","NOT_YET_RECRUITING","Innsbruck","Austria","AT",{"type":50,"coordinates":51},"Point",[52,53],11.39454,47.26266,{"lat":53,"lon":52},[56],{"name":57,"role":36,"phone":18,"phoneExt":18,"email":18},"Michael Joannidis, Prof. Dr.",{"facility":59,"status":45,"city":60,"state":18,"zip":18,"country":47,"countryCode":48,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"University Hospital Vienna","Vienna",{"type":50,"coordinates":62},[63,64],16.37208,48.20849,{"lat":64,"lon":63},[67],{"name":68,"role":36,"phone":18,"phoneExt":18,"email":18},"Peter Schellongowski, Prof. Dr.",{"facility":70,"status":45,"city":71,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"St. Joseph Hospital","Berlin","Germany","DE",{"type":50,"coordinates":75},[76,77],13.41053,52.52437,{"lat":77,"lon":76},[80],{"name":81,"role":36,"phone":18,"phoneExt":18,"email":82},"Christoph Buettner","Christoph.Buettner@sjk.de",{"facility":84,"status":45,"city":71,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":85,"geoPoint":87,"contacts":88},"University Hospital Berlin Charite",{"type":50,"coordinates":86},[76,77],{"lat":77,"lon":76},[89],{"name":90,"role":36,"phone":18,"phoneExt":18,"email":91},"Philipp Enghard, PD Dr.","philipp.enghard@charite.de",{"facility":93,"status":94,"city":95,"state":18,"zip":96,"country":72,"countryCode":73,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"University Hospital Bonn","RECRUITING","Bonn","53127",{"type":50,"coordinates":98},[99,100],7.09549,50.73438,{"lat":100,"lon":99},[103],{"name":32,"role":36,"phone":104,"phoneExt":18,"email":105},"+49 (0)228 281 14119","christian.bode@ukbonn.de",{"facility":107,"status":45,"city":108,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Hospital Braunschweig","Braunschweig",{"type":50,"coordinates":110},[111,112],10.52673,52.26594,{"lat":112,"lon":111},[115],{"name":116,"role":36,"phone":18,"phoneExt":18,"email":18},"Jan T. Kielstein, Prof. Dr.",{"facility":118,"status":45,"city":119,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Hospital Bremerhaven","Bremerhaven",{"type":50,"coordinates":121},[122,123],8.57553,53.55357,{"lat":123,"lon":122},[126],{"name":127,"role":36,"phone":18,"phoneExt":18,"email":128},"Joern Bramstedt, Dr.","Joern.Bramstedt@klinikum-bremerhaven.de",{"facility":130,"status":45,"city":131,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Hospital Cologne Meerheim","Cologne",{"type":50,"coordinates":133},[134,135],6.95,50.93333,{"lat":135,"lon":134},[138],{"name":139,"role":36,"phone":18,"phoneExt":18,"email":140},"Achim Joerres, Prof. Dr.","joerresa@kliniken-koeln.de",{"facility":142,"status":45,"city":131,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":143,"geoPoint":145,"contacts":146},"University Hospital Cologne",{"type":50,"coordinates":144},[134,135],{"lat":135,"lon":134},[147],{"name":148,"role":36,"phone":18,"phoneExt":18,"email":149},"Matthias Kochanek, Prof. Dr.","matthias.kochanek@uk-koeln.de",{"facility":151,"status":45,"city":152,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"University Hospital Erlangen","Erlangen",{"type":50,"coordinates":154},[155,156],11.00783,49.59099,{"lat":156,"lon":155},[159],{"name":160,"role":36,"phone":18,"phoneExt":18,"email":161},"Carsten Willam, Prof. Dr.","Carsten.Willam@uk-erlangen.de",{"facility":163,"status":45,"city":164,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"University Hospital Essen","Essen",{"type":50,"coordinates":166},[167,168],7.01228,51.45657,{"lat":168,"lon":167},[171],{"name":172,"role":36,"phone":18,"phoneExt":18,"email":173},"Thorsten Brenner, Prof. Dr.","Thorsten.Brenner@uk-essen.de",{"facility":175,"status":176,"city":177,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":178,"geoPoint":182,"contacts":18},"University Hospital Halle","ACTIVE_NOT_RECRUITING","Halle",{"type":50,"coordinates":179},[180,181],11.97947,51.48158,{"lat":181,"lon":180},{"facility":184,"status":45,"city":185,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"University Hospital Hamburg (UKE)","Hamburg",{"type":50,"coordinates":187},[188,189],9.99302,53.55073,{"lat":189,"lon":188},[192],{"name":193,"role":36,"phone":18,"phoneExt":18,"email":18},"Stefan Kluge, Prof. Dr.",{"facility":195,"status":94,"city":196,"state":18,"zip":197,"country":72,"countryCode":73,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Hannover Medical School Anesthesiology","Hanover","30625",{"type":50,"coordinates":199},[200,201],9.73322,52.37052,{"lat":201,"lon":200},[204],{"name":205,"role":36,"phone":18,"phoneExt":18,"email":206},"Hans-Joerg Gillmann, Dr.","gillmann.hans-joerg@mh-hannover.de",{"facility":208,"status":94,"city":196,"state":18,"zip":197,"country":72,"countryCode":73,"cosmosGeoPoint":209,"geoPoint":211,"contacts":212},"Hannover Medical School Internal Medicine",{"type":50,"coordinates":210},[200,201],{"lat":201,"lon":200},[213],{"name":30,"role":36,"phone":40,"phoneExt":18,"email":41},{"facility":215,"status":45,"city":216,"state":18,"zip":217,"country":72,"countryCode":73,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"University Hospital Heidelberg","Heidelberg","69120",{"type":50,"coordinates":219},[220,221],8.69079,49.40768,{"lat":221,"lon":220},[224],{"name":225,"role":36,"phone":18,"phoneExt":18,"email":226},"Markus Weigand","Markus.Weigand@med.uni-heidelberg.de",{"facility":228,"status":45,"city":229,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"University Hospital Jena","Jena",{"type":50,"coordinates":231},[232,233],11.5899,50.92878,{"lat":233,"lon":232},[236],{"name":237,"role":36,"phone":18,"phoneExt":18,"email":238},"Michael Bauer, Prof. Dr.","michael.bauer@med.uni-jena.de",{"facility":240,"status":45,"city":241,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"University Hospital Kiel","Kiel",{"type":50,"coordinates":243},[244,245],10.13489,54.32133,{"lat":245,"lon":244},[248],{"name":249,"role":36,"phone":18,"phoneExt":18,"email":250},"Norbert Weiler, Prof. Dr.","norbert.weiler@uksh.de",{"facility":252,"status":45,"city":253,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"Hospital Magdeburg","Magdeburg",{"type":50,"coordinates":255},[256,257],11.63189,52.13129,{"lat":257,"lon":256},[260],{"name":261,"role":36,"phone":18,"phoneExt":18,"email":262},"Martin Sauer, Prof. Dr.","Martin.Sauer@Klinikum-Magdeburg.de",{"facility":264,"status":45,"city":265,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"University Hospital Munich (TUM) Anesthesiology","Munich",{"type":50,"coordinates":267},[268,269],11.57549,48.13743,{"lat":269,"lon":268},[272],{"name":273,"role":36,"phone":18,"phoneExt":18,"email":274},"Markus Heim, Dr.","m.heim@tum.de",{"facility":276,"status":45,"city":265,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":277,"geoPoint":279,"contacts":280},"University Hospital Munich (TUM) Internal Medicine",{"type":50,"coordinates":278},[268,269],{"lat":269,"lon":268},[281],{"name":282,"role":36,"phone":18,"phoneExt":18,"email":18},"Tobias Lahmer, PD Dr.",{"facility":284,"status":45,"city":285,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":286,"geoPoint":290,"contacts":291},"University Hospital Muenster Anesthesiology","Münster",{"type":50,"coordinates":287},[288,289],7.62571,51.96236,{"lat":289,"lon":288},[292],{"name":293,"role":36,"phone":18,"phoneExt":18,"email":294},"Alexander Zarbock, Prof. Dr.","zarbock@uni-muenster.de",{"facility":296,"status":45,"city":297,"state":18,"zip":18,"country":72,"countryCode":73,"cosmosGeoPoint":298,"geoPoint":302,"contacts":303},"University Hospital Rostock","Rostock",{"type":50,"coordinates":299},[300,301],12.14049,54.0887,{"lat":301,"lon":300},[304],{"name":305,"role":36,"phone":18,"phoneExt":18,"email":306},"Steffen Mitzner, Prof. Dr.","steffen.mitzner@med.uni-rostock.de",{"facility":308,"status":45,"city":309,"state":18,"zip":18,"country":310,"countryCode":311,"cosmosGeoPoint":312,"geoPoint":316,"contacts":317},"University Hospital Bern","Bern","Switzerland","CH",{"type":50,"coordinates":313},[314,315],7.44744,46.94809,{"lat":315,"lon":314},[318],{"name":319,"role":36,"phone":18,"phoneExt":18,"email":18},"Joerg C. Schefold",{"facility":321,"status":45,"city":322,"state":18,"zip":323,"country":310,"countryCode":311,"cosmosGeoPoint":324,"geoPoint":328,"contacts":329},"University Hospital Zurich","Zurich","8091",{"type":50,"coordinates":325},[326,327],8.55,47.36667,{"lat":327,"lon":326},[330],{"name":26,"role":36,"phone":37,"phoneExt":18,"email":38},{"type":332,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100495103","efficacy-of-add-on-plasma-exchange-as-an-adjunctive-strategy-against-septic-shock-100495103",false,"NCT05726825","Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic Shock","Randomized, Prospective, Multicenter, Open-label, Controlled, Parallel-group Trial Investigating the Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic Shock - 2","EXCHANGE-2","Inclusion Criteria:\n\n* New onset of septic shock (\\\u003C 24 hrs), (SEPSIS-3 definition)\n* Norepinephrine (NE) dose ≥ 0.4 μg\u002Fkg\u002Fmin ≥ 30 min OR NE ≥ 0.3 μg\u002Fkg\u002Fmin + vasopressin (any dose)\n* Established vascular access suitable for plasma exchange independent of study inclusion (due to established indication of RRT, expected need for RRT within the next 48 hours or other medical reasons as assessed by treating physician team)\n\nExclusion Criteria:\n\n* Age \\\u003C 18 or \\> 80 years\n* Urogenital focus of infection\n* Pregnancy\n* Heparin-induced thrombocytopenia\n* Known reaction against fresh frozen plasma (FFP)","ALL","18 Years","80 Years",{"count":345,"type":346},274,"ESTIMATED","INTERVENTIONAL",[349],"NA","Randomized, prospective, multicenter, open-label, controlled, parallel-group interventional trial to test the adjunctive effect of therapeutic plasma exchange in patients with early septic shock.",[352],"Septic Shock",[352,354,355,356,357],"Sepsis","Multi-organ failure","Extracorporeal therapy","Plasmapheresis","2025-03-11",{"date":360,"type":361},"2025-03-13","ACTUAL",{"date":363,"type":361},"2025-02-19",{"date":365,"type":346},"2028-04",{"name":5,"class":6},25]