[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656928":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":40,"studyPopulation":40,"armGroups":47,"interventions":58,"overallOfficials":40,"centralContacts":64,"locations":73,"responsibleParty":92,"collaborators":96,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":40,"enrollmentInfo":109,"targetDuration":40,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":75,"whyStopped":40,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"Proteomics","Delta proteomics pathway analysis between baseline and after 48 hours of enrollment.","From enrollment until 48 hours after enrollment",[14,18,22,25,28,31,34,37],{"measure":15,"description":16,"timeFrame":17},"Mortality","The effect of external warming of afebrile septic patients on mortality","30 days",{"measure":19,"description":20,"timeFrame":21},"Organ failure","To assess the effect of external warming of afebrile septic patients on organ failure.","until end of ICU stay, approximately 30 days",{"measure":23,"description":24,"timeFrame":21},"Length of ICU stay","To assess the effect of external warming of afebrile septic patients on length of ICU-stay",{"measure":26,"description":27,"timeFrame":21},"Nosocomial infections","To assess the effect of external warming of afebrile septic patients on nosocomial infections.",{"measure":29,"description":24,"timeFrame":30},"Length of hospital stay","until discharge, approximately 30 days until 3 months",{"measure":32,"description":33,"timeFrame":12},"Microcirculation","To assess the impact of therapeutic hyperthermia in afebrile septic patients on microcirculation measured sublingually",{"measure":35,"description":36,"timeFrame":12},"Hemodynamics","To assess the impact of external warming in afebrile septic patients on hemodynamics",{"measure":38,"description":39,"timeFrame":12},"Mitochondrial oxygen tension","To assess the impact of external warming in afebrile septic patients on mitochondrial oxygen tension",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":44,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":46,"maskingDescription":40,"whoMasked":40},"NONE",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"External Warming","EXPERIMENTAL","Intervention with External Warming",[53],"Other: External Warming",{"label":55,"type":56,"description":57,"interventionNames":40},"Control","NO_INTERVENTION","Control group according to standard clinical practice",[59],{"type":6,"name":49,"description":60,"armGroupLabels":61,"otherNames":62},"External Warming with the Arctic Sun 5000",[49],[63],"Therapeutic Hyperthermia",[65,70],{"name":66,"role":67,"phone":68,"phoneExt":40,"email":69},"Denyse Paalvast","CONTACT","+31639311643","d.paalvast@erasmusmc.nl",{"name":71,"role":67,"phone":40,"phoneExt":40,"email":72},"Matthew B.A. Harmon","m.harmon@erasmusmc.nl",[74],{"facility":5,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"RECRUITING","Rotterdam","South Holland","3015GD","Netherlands","NL",{"type":82,"coordinates":83},"Point",[84,85],4.47917,51.9225,{"lat":85,"lon":84},[88,89,90],{"name":66,"role":67,"phone":68,"phoneExt":40,"email":69},{"name":71,"role":67,"phone":40,"phoneExt":40,"email":72},{"name":66,"role":91,"phone":40,"phoneExt":40,"email":40},"SUB_INVESTIGATOR",{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"SPONSOR_INVESTIGATOR","Matt Harmon","Principal Investigator",[97],{"name":98,"class":99},"BD Technologies, Research Triangle Park, NC","UNKNOWN","100656928","temperature-optimization-in-afebrile-septic-patients-100656928",false,"NCT07831057","Temperature Optimization in Afebrile Septic PatienTs","TOAST","Inclusion Criteria:\n\n* Sepsis according to the SEPSIS-3 definition\n* Sedated and intubated\n* Highest temperature \\\u003C 38,3 degrees Celsius\n\nExclusion Criteria:\n\nA potential participant who meets any of the following criteria will be excluded from participation in this study:\n\n* Patients with immunologic diseases:\n* human immunodeficiency virus\n* neutropenia\n* history of chronic infection with hepatitis B or C virus\n\nPatients using immune suppressing medications:\n\n* treatment with corticosteroids at a dose of \\> 300 mg\u002Fday hydrocortisone or equivalent at the time of enrollment;\n* Tacrolimus\n* Mycophenolate mofetil\n* Ciclofosfamide\n\nPatients with a contraindication for therapeutic hyperthermia:\n\n* cardiac arrest\n* acute ischemic stroke\n* acute coronary syndrome\n* traumatic brain injury\n* spinal cord injury\n* sickle cell disease\n* multiple sclerosis\n* Pregnancy\n* Moribund patients (expected death within 48 hours)\n* Contraindications to forced air warming devices per manufacture instructions (i.e. ischemic limbs)","ALL","18 Years",{"count":110,"type":111},50,"ESTIMATED","INTERVENTIONAL",[114],"NA","The goal of this interventional study is to learn if external warming works to treat patients with a serious systemic infection (i.e. sepsis) that do not have fever. These patients have a higher risk of dying than patients with fever. It is possible that these patients might benefit from artificial external warming with the means to increase body temperature. It is unknown what the mechanism is, but it might be related to the immune system and how the body manages blood pressure and perfusion.\n\nThe main questions to answer are:\n\n* Does external warming of the body influence certain inflammatory proteins in the blood?\n* Does external warming of the body influence prognosis and\u002For clinical condition? Researchers will compare external warming to standard clinical practice to see if external warming works to treat sepsis without fever.\n\nParticipants will:\n\n\\- receive treatment with external warming or treatment according to clinical practice",[117,118],"Sepsis","Temperature",[117,120,121,122,123,105,124,49,63],"Temperature Optimization","Temperature Management","Afebrile","Hypothermic","Septic Patients","2026-09-15",{"date":127,"type":128},"2026-09-21","ACTUAL",{"date":130,"type":128},"2026-07-17",{"date":132,"type":111},"2027-07",{"name":94,"class":6},1]