[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567423":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":56,"centralContacts":66,"locations":74,"responsibleParty":393,"collaborators":397,"id":453,"slug":454,"hasResults":455,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":455,"sex":461,"minAge":462,"maxAge":40,"enrollmentInfo":463,"targetDuration":40,"studyType":466,"phases":467,"briefSummary":469,"conditions":470,"keywords":474,"overallStatus":96,"whyStopped":40,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":489},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14,19,24,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Albumin","EXPERIMENTAL","Use of albumin in ICU during circulatory failure in addition to crystalloids (resuscitation) and for substitution in case of suspected or overt albumin loss or plasma albumin levels ≤25 g\u002FL",[13],"Drug: Albumin",{"label":15,"type":6,"description":16,"interventionNames":17},"No albumin use","No albumin is to be used in ICU unless specific events occur",[18],"Other: No albumin use",{"label":20,"type":10,"description":21,"interventionNames":22},"Low-molecular-weight heparin for thromboprophylaxis in weight-adjusted dose","Use of low-molecular-weight heparin for thromboprophylaxis in weight-adjusted dose during ICU stay",[23],"Drug: LMWH in weight-adjusted dose",{"label":25,"type":26,"description":27,"interventionNames":28},"Low-molecular-weight heparin for thromboprophylaxis in fixed low dose","ACTIVE_COMPARATOR","Use of low-molecular-weight heparin for thromboprophylaxis in fixed low dose during ICU stay",[29],"Drug: LMWH in fixed low dose",{"label":31,"type":26,"description":32,"interventionNames":33},"Low-molecular-weight heparin for thromboprophylaxis in fixed intermediate dose","Use of low-molecular-weight heparin for thromboprophylaxis in fixed intermediate dose during ICU stay",[34],"Drug: LMWH in fixed intermediate dose",[36,41,44,48,52],{"type":37,"name":9,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Albumin should be used for the following indications: 1. During circulatory failure in addition to crystalloids (resuscitation). 2. For substitution in case of: suspected or overt albumin loss OR P-albumin levels below or equal to 25 g\u002FL. Decisions around timing, volume, and concentration of albumin, and its use for other indications, are at the clinician's discretion. P-albumin should be measured according to local practice.",[9],null,{"type":6,"name":15,"description":42,"armGroupLabels":43,"otherNames":40},"Albumin should not be used. In case of the following special circumstances, albumin may be considered: 1. Large ascites drainage (i.e., equal to or more than 1 L tapped) 2. Spontaneous bacterial peritonitis 3. Hepatorenal syndrome.",[15],{"type":37,"name":45,"description":46,"armGroupLabels":47,"otherNames":40},"LMWH in weight-adjusted dose","Patients with indication for thromboprophylaxis receive low-molecular-weight heparin (LMWH) in a weight-adjusted dose during their ICU stay. The treating clinician may decide to adjust or withhold one or more doses in case of acute and\u002For chronic kidney injury, renal replacement therapy, thrombocytopenia, invasive procedures, use of thrombolysis, and active (major) bleeding.",[20],{"type":37,"name":49,"description":50,"armGroupLabels":51,"otherNames":40},"LMWH in fixed low dose","Patients with indication for thromboprophylaxis receive low-molecular-weight heparin (LMWH) in a fixed low dose during their ICU stay. The treating clinician may decide to adjust or withhold one or more doses in case of acute and\u002For chronic kidney injury, renal replacement therapy, thrombocytopenia, invasive procedures, use of thrombolysis, and active (major) bleeding.",[25],{"type":37,"name":53,"description":54,"armGroupLabels":55,"otherNames":40},"LMWH in fixed intermediate dose","Patients with indication for thromboprophylaxis receive low-molecular-weight heparin (LMWH) in a fixed intermediate dose during their ICU stay. The treating clinician may decide to adjust or withhold one or more doses in case of acute and\u002For chronic kidney injury, renal replacement therapy, thrombocytopenia, invasive procedures, use of thrombolysis, and active (major) bleeding.",[31],[57,61,64],{"name":58,"affiliation":59,"role":60},"Anders Perner, Professor","Copenhagen University Hospital - Rigshospitalet, Department of Intensive Care","STUDY_CHAIR",{"name":62,"affiliation":59,"role":63},"Anders Granholm, MD","PRINCIPAL_INVESTIGATOR",{"name":65,"affiliation":59,"role":63},"Morten H Moeller, 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Koch, MD, Consultant",{"facility":130,"status":96,"city":116,"state":40,"zip":117,"country":80,"countryCode":81,"cosmosGeoPoint":131,"geoPoint":133,"contacts":134},"Department of Intensive Care Øst, Aarhus University Hospital",{"type":83,"coordinates":132},[120,121],{"lat":121,"lon":120},[135,139],{"name":136,"role":68,"phone":137,"phoneExt":40,"email":138},"Asger Granfeldt, MD, Professor","004529720155","asgegran@rm.dk",{"name":136,"role":63,"phone":40,"phoneExt":40,"email":40},{"facility":141,"status":77,"city":142,"state":40,"zip":143,"country":80,"countryCode":81,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Department of Cardiothoracic Anaesthesia and Intensive care, Copenhagen Universisty Hospital - Rigshospitalet","Copenhagen","2100",{"type":83,"coordinates":145},[146,147],12.56553,55.67594,{"lat":147,"lon":146},[150,154],{"name":151,"role":68,"phone":152,"phoneExt":40,"email":153},"Peter B Hjortrup, MD, 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Hospital","Herning","7400",{"type":83,"coordinates":224},[225,226],8.97662,56.13615,{"lat":226,"lon":225},[229,233],{"name":230,"role":68,"phone":231,"phoneExt":40,"email":232},"Iben S Darfelt, MD","004548310086","ibedar@rm.dk",{"name":230,"role":63,"phone":40,"phoneExt":40,"email":40},{"facility":235,"status":96,"city":236,"state":40,"zip":237,"country":80,"countryCode":81,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"Department of Anaesthesia and Intensive Care Medicine, Copenhagen University Hospital - North Zealand","Hillerød","3400",{"type":83,"coordinates":239},[240,241],12.30081,55.92791,{"lat":241,"lon":240},[244,248],{"name":245,"role":68,"phone":246,"phoneExt":40,"email":247},"Morten H Bestle, MD","004541951195","morten.bestle@regionh.dk",{"name":245,"role":63,"phone":40,"phoneExt":40,"email":40},{"facility":250,"status":96,"city":251,"state":40,"zip":252,"country":80,"countryCode":81,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"Anaesthesiology and Intensive Care, Amager and Hvidovre Hospital","Hvidovre","2650",{"type":83,"coordinates":254},[255,256],12.47708,55.64297,{"lat":256,"lon":255},[259,263],{"name":260,"role":68,"phone":261,"phoneExt":40,"email":262},"Ronni TR Plovsing, MD, PhD","004538620721","ronni.thermann.reitz.plovsing.01@regionh.dk",{"name":260,"role":63,"phone":40,"phoneExt":40,"email":40},{"facility":265,"status":96,"city":266,"state":40,"zip":267,"country":80,"countryCode":81,"cosmosGeoPoint":268,"geoPoint":272,"contacts":273},"Department of Anesthesia and intensive care medicine, Kolding Hospital","Kolding","6000",{"type":83,"coordinates":269},[270,271],9.47216,55.4904,{"lat":271,"lon":270},[274,278],{"name":275,"role":68,"phone":276,"phoneExt":40,"email":277},"Anne C Brøchner, MD, Consultant","004529464468","Anne.craveiro.broechner@rsyd.dk",{"name":275,"role":63,"phone":40,"phoneExt":40,"email":40},{"facility":280,"status":96,"city":281,"state":40,"zip":282,"country":80,"countryCode":81,"cosmosGeoPoint":283,"geoPoint":287,"contacts":288},"Department of Anesthesia, Zealand University Hospital","Køge","4600",{"type":83,"coordinates":284},[285,286],12.18214,55.45802,{"lat":286,"lon":285},[289,293,297],{"name":290,"role":68,"phone":291,"phoneExt":40,"email":292},"Lars Peter K Andersen, MD, Ph.D","+45 31518908","lpka@regionsjaelland.dk",{"name":294,"role":68,"phone":295,"phoneExt":40,"email":296},"Louise S Herløv, Project nurse","+45 47 32 63 11","lherl@regionsjaelland.dk",{"name":290,"role":63,"phone":40,"phoneExt":40,"email":40},{"facility":299,"status":77,"city":300,"state":40,"zip":301,"country":80,"countryCode":81,"cosmosGeoPoint":302,"geoPoint":306,"contacts":307},"Anesthesiology (ICU), Zealand University Hospital, Nykøbing Falster","Nykøbing Falster","4800",{"type":83,"coordinates":303},[304,305],11.87425,54.76906,{"lat":305,"lon":304},[308,312],{"name":309,"role":68,"phone":310,"phoneExt":40,"email":311},"Hans Fjeldsøe-Nielsen, MD","004556515607","hafj@regionsjaelland.dk",{"name":309,"role":63,"phone":40,"phoneExt":40,"email":40},{"facility":314,"status":96,"city":315,"state":40,"zip":316,"country":80,"countryCode":81,"cosmosGeoPoint":317,"geoPoint":321,"contacts":322},"Department of Anesthesiology and Intensive Care, Odense University Hospital","Odense","5000",{"type":83,"coordinates":318},[319,320],10.38831,55.39594,{"lat":320,"lon":319},[323,327],{"name":324,"role":68,"phone":325,"phoneExt":40,"email":326},"Jens Michelsen, MD","004565413365","Jens.michelsen3@rsyd.dk",{"name":324,"role":63,"phone":40,"phoneExt":40,"email":40},{"facility":329,"status":96,"city":330,"state":40,"zip":331,"country":80,"countryCode":81,"cosmosGeoPoint":332,"geoPoint":336,"contacts":337},"Operation og Intensiv, Regional Hospital Randers","Randers","8930",{"type":83,"coordinates":333},[334,335],10.03639,56.4607,{"lat":335,"lon":334},[338,342],{"name":339,"role":68,"phone":340,"phoneExt":40,"email":341},"Marianne L Vang, MD","004578420505","marivang@rm.dk",{"name":339,"role":63,"phone":40,"phoneExt":40,"email":40},{"facility":344,"status":96,"city":345,"state":40,"zip":346,"country":80,"countryCode":81,"cosmosGeoPoint":347,"geoPoint":351,"contacts":352},"Intensive care, Slagelse Hospital","Slagelse","4200",{"type":83,"coordinates":348},[349,350],11.35459,55.40276,{"lat":350,"lon":349},[353,357,361],{"name":354,"role":68,"phone":355,"phoneExt":40,"email":356},"Anne G Vedel, MD, Senior Registrar","004560660882","agse@regionsjaelland.dk",{"name":358,"role":68,"phone":359,"phoneExt":40,"email":360},"Susanne A Iversen, Leading Physician","004524951801","saiv@regionsjaelland.dk",{"name":362,"role":63,"phone":40,"phoneExt":40,"email":40},"Anne G Vedel, MD, Senior registrar",{"facility":364,"status":96,"city":365,"state":40,"zip":366,"country":80,"countryCode":81,"cosmosGeoPoint":367,"geoPoint":371,"contacts":372},"Department. of Anesthesiology and Intensive Care Medicine","Svendborg","5700",{"type":83,"coordinates":368},[369,370],10.60677,55.05982,{"lat":370,"lon":369},[373,377],{"name":374,"role":68,"phone":375,"phoneExt":40,"email":376},"Peter M Hansen, MD, Consultant","+4520629319","peter.martin.hansen@rsyd.dk",{"name":374,"role":63,"phone":40,"phoneExt":40,"email":40},{"facility":379,"status":96,"city":380,"state":40,"zip":381,"country":80,"countryCode":81,"cosmosGeoPoint":382,"geoPoint":386,"contacts":387},"Department of Anaesthesiology and Intensive Care, Regional Hospital Viborg","Viborg","8800",{"type":83,"coordinates":383},[384,385],9.40201,56.45319,{"lat":385,"lon":384},[388,392],{"name":389,"role":68,"phone":390,"phoneExt":40,"email":391},"Christoffer G Sølling, MD, PhD","004561787862","chrisl@rm.dk",{"name":389,"role":63,"phone":40,"phoneExt":40,"email":40},{"type":394,"investigatorFullName":395,"investigatorTitle":396,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"SPONSOR_INVESTIGATOR","Anders Perner","Professor, senior staff specialist",[398,399,401,403,405,407,409,411,413,415,417,419,421,423,425,427,430,432,434,436,438,440,442,444,446,449,451],{"name":5,"class":6},{"name":400,"class":6},"Bispebjerg Hospital",{"name":402,"class":6},"Herlev Hospital",{"name":404,"class":6},"Hillerod Hospital, Denmark",{"name":406,"class":6},"Kolding Sygehus",{"name":408,"class":6},"Zealand University Hospital",{"name":410,"class":6},"Slagelse Hospital",{"name":412,"class":6},"Viborg Regional Hospital",{"name":414,"class":6},"Aalborg University Hospital",{"name":416,"class":6},"Aarhus University Hospital",{"name":418,"class":6},"Gødstrup Hospital",{"name":420,"class":6},"Copenhagen University Hospital, Hvidovre",{"name":422,"class":6},"Odense University Hospital",{"name":424,"class":6},"Randers Regional Hospital",{"name":426,"class":6},"University of Copenhagen",{"name":428,"class":429},"North Denmark Region","OTHER_GOV",{"name":431,"class":6},"Region Capital Denmark",{"name":433,"class":6},"Region Zealand",{"name":435,"class":6},"University Medical Center Groningen",{"name":437,"class":6},"Steno Diabetes Center Copenhagen",{"name":439,"class":6},"Karolinska Institutet",{"name":441,"class":6},"Oslo University Hospital",{"name":443,"class":6},"University Hospital, Basel, Switzerland",{"name":445,"class":6},"Tampere University",{"name":447,"class":448},"Collaboration of Research in Intensive Care","UNKNOWN",{"name":450,"class":448},"Danish Intensive Care Database",{"name":452,"class":448},"The National University Hospital of Iceland","100567423","phase-4-the-intensive-care-platform-trial-100567423",false,"NCT06667999","The Intensive Care Platform Trial","The Intensive Care Platform Trial (INCEPT)","INCEPT","The general eligibility criteria below apply to INCEPT as a whole and thus to all domains. Domains may impose domain-specific eligibility criteria that restrict the population eligible for that domain further, but domains are not allowed to broaden the general eligibility criteria. Domain-specific eligibility criteria always apply to all arms in a domain.\n\nPLATFORM INCLUSION CRITERIA:\n\n* Adult patient (≥18 years old) acutely admitted to the ICU. This includes ICU admissions after emergency surgery, unplanned ICU admissions after elective surgery, and prolonged ICU admissions due to complications after elective surgery (i.e., admissions occurring or being prolonged due to an unexpected, worsened condition, but excluding planned ICU admissions after elective surgery without clinical deterioration).\n* Eligible for at least one active domain.\n\nPLATFORM EXCLUSION CRITERIA:\n\n* Informed consent following inclusion expected to be unobtainable (e.g., known previous objections to participation).\n* Patient is under coercive measures (e.g., ongoing involuntary hospital stay or under the jurisdiction of correctional authorities).\n\nPatients who have previously been included in INCEPT may only be included again during new ICU admissions but may only be randomised to domains in which they have not previously been randomised.\n\nDOMAIN-SPECIFIC ELIGIBLE CRITERIA:\n\nEach domain may have additional eligibility criteria. Refer to the study website for more information (www.incept.dk).","ALL","18 Years",{"count":464,"type":465},10000,"ESTIMATED","INTERVENTIONAL",[468],"PHASE4","Among critically ill patients, many die, and many of the survivors and their family members struggle for years with reduced quality of life. Critically ill patients are treated in intensive care units (ICUs). Here, they receive life support, e.g., mechanical ventilation and advanced support of the circulation (heart and blood vessels) and kidneys. In addition, ICU patients receive many other treatments. It is, however, uncertain if all the treatments provide value for the patients. The desirable effects of many treatments are uncertain, and some may be wasteful or even harmful.\n\nClinical trials are necessary to validly assess the desirable and undesirable effects of different treatments. However, conventional clinical trials have limitations:\n\n* They typically only assess a single question related to a single comparison of treatments at a time.\n* They are often not very flexible, including with regards to the number of participants needed, and this increases the risk that a trial will end up as inconclusive.\n* There is no or limited re-use or sharing of infrastructure across trials, leading to duplicate work and resource use.\n* Trial participants do usually not benefit from the obtained knowledge before the trial concludes.\n* Involvement of patients, family members, and other stakeholders is typically limited, which may decrease the relevance of the questions addressed.\n\nWith the Intensive Care Platform Trial (INCEPT), we aim to tackle these challenges by establishing a flexible platform trial that continuously learns from the obtained results. The platform trial may run forever with simultaneous and continuous assessment of many treatments. INCEPT will continuously learn from the accrued data and use these to improve the treatment of both participating and future patients. With INCEPT, we are also building a framework for thorough and extensive involvement of key stakeholders, including patients and family members. INCEPT will improve the way clinical trials are done and increase the probabilities that treatments are improved. This will:\n\n* Directly improve outcomes for ICU patients.\n* Relieve a strained healthcare system by discarding inefficient or harmful treatments.\n* Ensure that new treatments are beneficial or cost-effective before implementation.\n* Lower the costs and burdens of assessing more treatments in the critically ill.",[471,472,473],"Intensive Care Patients","Intensive Care Unit Patients","Critical Illness",[475,476,477,478,479],"Platform trial","Intensive care","Intensive care unit","Critical illness","Clinical platform trial","2026-03-18",{"date":482,"type":483},"2026-03-19","ACTUAL",{"date":485,"type":483},"2025-06-26",{"date":487,"type":465},"2035-12",{"name":395,"class":6},21]