[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601031":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":45,"responsibleParty":158,"collaborators":27,"id":160,"slug":27,"hasResults":161,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":161,"sex":167,"minAge":168,"maxAge":27,"enrollmentInfo":169,"targetDuration":27,"studyType":172,"phases":173,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":48,"whyStopped":27,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},{"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",[46,64,80,91,106,121,136,147],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Rijnstate Ziekenhuis Stichting","RECRUITING","Arnhem","Gelderland","6815AD","Netherlands",{"type":54,"coordinates":55},"Point",[56,57],5.91111,51.98,{"lat":57,"lon":56},[60],{"name":61,"role":39,"phone":62,"phoneExt":27,"email":63},"Aart Strang, Mr.","+31880056969","astrang@rijnstate.nl",{"facility":65,"status":48,"city":66,"state":50,"zip":67,"country":52,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Intensive Care Medicine, Radboud University","Nijmegen","6500 HB",{"type":54,"coordinates":69},[70,71],5.85278,51.8425,{"lat":71,"lon":70},[74,75,77],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},{"name":43,"role":76,"phone":27,"phoneExt":27,"email":27},"PRINCIPAL_INVESTIGATOR",{"name":78,"role":79,"phone":27,"phoneExt":27,"email":27},"Jonne Doorduin, PhD","SUB_INVESTIGATOR",{"facility":81,"status":48,"city":66,"state":50,"zip":82,"country":52,"cosmosGeoPoint":83,"geoPoint":85,"contacts":86},"Canisius Wilhelmina Ziekenhuis","6532SZ",{"type":54,"coordinates":84},[70,71],{"lat":71,"lon":70},[87],{"name":88,"role":39,"phone":89,"phoneExt":27,"email":90},"Oscar Hoiting, Dr.","+31243657560","o.hoiting@cwz.nl",{"facility":92,"status":48,"city":93,"state":94,"zip":95,"country":52,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Jeroen Bosch Ziekenhuis Stichting","'s-Hertogenbosch","North Brabant","5223GZ",{"type":54,"coordinates":97},[98,99],5.30417,51.69917,{"lat":99,"lon":98},[102],{"name":103,"role":39,"phone":104,"phoneExt":27,"email":105},"Koen Simons, Dr.","+31735532447","k.simons@jbz.nl",{"facility":107,"status":108,"city":109,"state":94,"zip":110,"country":52,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Catharina Ziekenhuis Stichting","NOT_YET_RECRUITING","Eindhoven","5623EJ",{"type":54,"coordinates":112},[113,114],5.47778,51.44083,{"lat":114,"lon":113},[117],{"name":118,"role":39,"phone":119,"phoneExt":27,"email":120},"Ashley de Bie, Dr.","+31402399500","ashley.d.bie@catharinaziekenhuis.nl",{"facility":122,"status":108,"city":123,"state":124,"zip":125,"country":52,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)","Rotterdam","South Holland","3015GD",{"type":54,"coordinates":127},[128,129],4.47917,51.9225,{"lat":129,"lon":128},[132],{"name":133,"role":39,"phone":134,"phoneExt":27,"email":135},"Annemijn Jonkman, Dr.","+31107035142","a.jonkman@erasmusmc.nl",{"facility":137,"status":48,"city":123,"state":124,"zip":138,"country":52,"cosmosGeoPoint":139,"geoPoint":141,"contacts":142},"Sint Franciscus Vlietland Groep Stichting","3045 PM",{"type":54,"coordinates":140},[128,129],{"lat":129,"lon":128},[143],{"name":144,"role":39,"phone":145,"phoneExt":27,"email":146},"Evert-Jan Wils","+31104616161","e.wils@franciscus.nl",{"facility":148,"status":48,"city":123,"state":124,"zip":149,"country":52,"cosmosGeoPoint":150,"geoPoint":152,"contacts":153},"Maasstad Ziekenhuis Stichting","3079DZ",{"type":54,"coordinates":151},[128,129],{"lat":129,"lon":128},[154],{"name":155,"role":39,"phone":156,"phoneExt":27,"email":157},"Corstiaan den Uil, Mr.","+31102913088","uilc@maasstadziekenhuis.nl",{"type":159,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","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":170,"type":171},250,"ESTIMATED","INTERVENTIONAL",[174],"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.",[177,178],"Mechanical Ventilation","Weaning Failure",[180,181,182,24,183],"mechanical ventilation","weaning","critically ill patients","diaphragm","2026-01-08",{"date":186,"type":187},"2026-01-09","ACTUAL",{"date":189,"type":187},"2025-09-17",{"date":191,"type":171},"2028-08-01",{"name":5,"class":6},8]