[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601031":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":45,"responsibleParty":159,"collaborators":27,"id":161,"slug":162,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":163,"sex":169,"minAge":170,"maxAge":27,"enrollmentInfo":171,"targetDuration":27,"studyType":174,"phases":175,"briefSummary":177,"conditions":178,"keywords":181,"overallStatus":48,"whyStopped":27,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","ACTIVE_COMPARATOR","Participants randomized to this arm will receive intravenous levosimendan. This group will consist of 125 patients.",[13,14],"Drug: levosimendan","Other: Standard care",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group","PLACEBO_COMPARATOR","Participants randomized to this arm will receive a placebo consisting of Soluvit. This group will consist of 125 participants.",[20,14],"Drug: Soluvit",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","levosimendan","Participants randomized to to the intervention will receive levosimendan. The infusion is administered over 24 hours, starting at a dose of 0.1 µg\u002Fkg\u002Fmin. After 4 hours, the dose may be increased to 0.2 µg\u002Fkg\u002Fmin if tolerated, based on clinical judgment. A maximum of four treatment cycles may be given if the patient is not successfully weaned from mechanical ventilation within 7 days.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Soluvit","Participants randomized to this arm will receive a placebo consisting of Soluvit diluted in glucose 5%, administered as an intravenous infusion over 24 hours. The infusion will mimic the Levosimendan administration protocol, starting at 0.1 µg\u002Fkg\u002Fmin and potentially increasing to 0.2 µg\u002Fkg\u002Fmin after 4 hours, to maintain blinding. A maximum of four placebo treatment cycles may be administered if the patient is not successfully weaned from mechanical ventilation within 7 days.",[16],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Standard care","All patients in this arm will receive standard ICU care, including daily assessments for readiness to wean from invasive ventilation.",[16,9],[37,42],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Esther de Leijer, MD","CONTACT","+31243668420","esther.deleijer@radboudumc.nl",{"name":43,"role":39,"phone":27,"phoneExt":27,"email":44},"Leo Heunks, MD, PhD","leo.heunks@radboudumc.nl",[46,65,81,92,107,122,137,148],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Rijnstate Ziekenhuis Stichting","RECRUITING","Arnhem","Gelderland","6815AD","Netherlands","NL",{"type":55,"coordinates":56},"Point",[57,58],5.91111,51.98,{"lat":58,"lon":57},[61],{"name":62,"role":39,"phone":63,"phoneExt":27,"email":64},"Aart Strang, Mr.","+31880056969","astrang@rijnstate.nl",{"facility":66,"status":48,"city":67,"state":50,"zip":68,"country":52,"countryCode":53,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Intensive Care Medicine, Radboud University","Nijmegen","6500 HB",{"type":55,"coordinates":70},[71,72],5.85278,51.8425,{"lat":72,"lon":71},[75,76,78],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},{"name":43,"role":77,"phone":27,"phoneExt":27,"email":27},"PRINCIPAL_INVESTIGATOR",{"name":79,"role":80,"phone":27,"phoneExt":27,"email":27},"Jonne Doorduin, PhD","SUB_INVESTIGATOR",{"facility":82,"status":48,"city":67,"state":50,"zip":83,"country":52,"countryCode":53,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"Canisius Wilhelmina Ziekenhuis","6532SZ",{"type":55,"coordinates":85},[71,72],{"lat":72,"lon":71},[88],{"name":89,"role":39,"phone":90,"phoneExt":27,"email":91},"Oscar Hoiting, Dr.","+31243657560","o.hoiting@cwz.nl",{"facility":93,"status":48,"city":94,"state":95,"zip":96,"country":52,"countryCode":53,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Jeroen Bosch Ziekenhuis Stichting","'s-Hertogenbosch","North Brabant","5223GZ",{"type":55,"coordinates":98},[99,100],5.30417,51.69917,{"lat":100,"lon":99},[103],{"name":104,"role":39,"phone":105,"phoneExt":27,"email":106},"Koen Simons, Dr.","+31735532447","k.simons@jbz.nl",{"facility":108,"status":109,"city":110,"state":95,"zip":111,"country":52,"countryCode":53,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Catharina Ziekenhuis Stichting","NOT_YET_RECRUITING","Eindhoven","5623EJ",{"type":55,"coordinates":113},[114,115],5.47778,51.44083,{"lat":115,"lon":114},[118],{"name":119,"role":39,"phone":120,"phoneExt":27,"email":121},"Ashley de Bie, Dr.","+31402399500","ashley.d.bie@catharinaziekenhuis.nl",{"facility":123,"status":109,"city":124,"state":125,"zip":126,"country":52,"countryCode":53,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)","Rotterdam","South Holland","3015GD",{"type":55,"coordinates":128},[129,130],4.47917,51.9225,{"lat":130,"lon":129},[133],{"name":134,"role":39,"phone":135,"phoneExt":27,"email":136},"Annemijn Jonkman, Dr.","+31107035142","a.jonkman@erasmusmc.nl",{"facility":138,"status":48,"city":124,"state":125,"zip":139,"country":52,"countryCode":53,"cosmosGeoPoint":140,"geoPoint":142,"contacts":143},"Sint Franciscus Vlietland Groep Stichting","3045 PM",{"type":55,"coordinates":141},[129,130],{"lat":130,"lon":129},[144],{"name":145,"role":39,"phone":146,"phoneExt":27,"email":147},"Evert-Jan Wils","+31104616161","e.wils@franciscus.nl",{"facility":149,"status":48,"city":124,"state":125,"zip":150,"country":52,"countryCode":53,"cosmosGeoPoint":151,"geoPoint":153,"contacts":154},"Maasstad Ziekenhuis Stichting","3079DZ",{"type":55,"coordinates":152},[129,130],{"lat":130,"lon":129},[155],{"name":156,"role":39,"phone":157,"phoneExt":27,"email":158},"Corstiaan den Uil, Mr.","+31102913088","uilc@maasstadziekenhuis.nl",{"type":160,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100601031","phase-4-shorter-weaning-from-invasive-ventilation-with-levosimendan-100601031",false,"NCT07105202","Shorter Weaning From Invasive Ventilation With Levosimendan","Shorter Weaning From Invasive Ventilation With Levosimendan: a Randomized, Double-blind, Multicentre Study in Critically Ill Patients","WEANLESS","Inclusion Criteria:\n\n* Invasively ventilated \\> 48 hours.\n* Failed at least one spontaneous breathing trial (SBT).\n* Age above 18 years.\n* Female patients with age \\\u003C 60 must have a negative pregnancy test (blood or urine) prior to participation.\n\nExclusion Criteria:\n\n* Pre-existing neuromuscular disease (congenital or acquired)\n* Endotracheally intubated primarily for neurological reason (e.g., traumatic brain injury, intracranial haemorrhage, epilepsy, intracranial infection), or developed severe intracranial haemorrhage\u002Finfarction during ICU stay.\n* Contra-indications for levosimendan: severe renal failure (creatinine clearance \\\u003C30mL\u002Fmin) unless managed with appropriate continuous kidney replacement therapy (such as CRRT), severe liver failure (Child-Pugh class C), history of torsade des pointes; known significant mechanical obstructions affecting ventricular filling\u002F outflow or both; prolonged QTc interval (QTc \\> 470ms); breast feeding; known hypersensitivity to levosimendan.\n* Treatment with intermittent haemodialysis.\n* Treatment limitation decision in place: do not reintubate\n* Previous treatment with levosimendan within 30 days.\n* Currently in another interventional trial that might interact with study drug or primary outcome.","ALL","18 Years",{"count":172,"type":173},250,"ESTIMATED","INTERVENTIONAL",[176],"PHASE4","Prolonged weaning from mechanical ventilation is a common and serious challenge in the ICU, associated with increased morbidity, mortality, and length of stay. Diaphragm dysfunction plays a key role in weaning failure, and current strategies to support respiratory muscle function are limited. Levosimendan is a calcium sensitizer that enhances cardiac and skeletal muscle contractility, including the diaphragm, without increasing oxygen demand.\n\nThe investigators hypothesize that treatment with Levosimendan in difficult-to-wean ICU patients will improve diaphragm function and thereby shorten the duration of mechanical ventilation compared to placebo.",[179,180],"Mechanical Ventilation","Weaning Failure",[182,183,184,24,185],"mechanical ventilation","weaning","critically ill patients","diaphragm","2026-01-08",{"date":188,"type":189},"2026-01-09","ACTUAL",{"date":191,"type":189},"2025-09-17",{"date":193,"type":173},"2028-08-01",{"name":5,"class":6},8]