[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626420":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":46,"locations":55,"responsibleParty":75,"collaborators":77,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":12,"enrollmentInfo":90,"targetDuration":12,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":105,"whyStopped":12,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Charles University, Czech Republic","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Propofol Group","NO_INTERVENTION","Standard Burn Care with Intravenous Sedation",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Isoflurane Group","EXPERIMENTAL","Burn-Bundle Extended Rehabilitation Program with Isoflurane Sedation",[18,19,20,21],"Other: Burn-Bundle Extended Rehabilitation Program","Drug: Isoflurane Inhalational Sedation","Device: Functional Proprioceptive Stimulation","Device: Neurorehabilitation Techniques",[23,27,32,37],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":12},"Burn-Bundle Extended Rehabilitation Program","A multimodal brain-activating rehabilitation program consisting of inhalational isoflurane sedation combined with functional proprioceptive stimulation, repetitive transcranial magnetic stimulation, and virtual reality-assisted rehabilitation when consciousness allows, applied during the acute phase after severe burn injury.",[14],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":12},"DRUG","Isoflurane Inhalational Sedation","Sedation with inhaled isoflurane administered via an anesthetic conserving device during invasive mechanical ventilation, used as an alternative to standard intravenous sedatives.",[14],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":12},"DEVICE","Functional Proprioceptive Stimulation","Illusory movements induced by focal vibration of muscle attachments to activate central motor pathways, applied twice daily during the acute phase of critical illness.",[14],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":12},"Neurorehabilitation Techniques","Non-invasive neurorehabilitation techniques including repetitive transcranial magnetic stimulation and virtual reality-assisted rehabilitation applied to enhance cortical activation and neuroplasticity in critically ill burn patients when clinically feasible.",[14],[42],{"name":43,"affiliation":44,"role":45},"Bohumil Bakalář, MD, PhD","University Hospital Kralovske Vinohrady Praha Czech Republic","PRINCIPAL_INVESTIGATOR",[47,51],{"name":43,"role":48,"phone":49,"phoneExt":12,"email":50},"CONTACT","+420 728816095","bohumil.bakalar@lf3.cuni.cz",{"name":52,"role":48,"phone":53,"phoneExt":12,"email":54},"Břetislav Lipový, MD, PhD, MBA","+420 26716 3392","bretislav.lipovy@fnkv.cz",[56],{"facility":57,"status":12,"city":58,"state":59,"zip":60,"country":61,"countryCode":12,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"University Hospital Královské Vinohrady","Prague","Česká Republika","100 34","Czechia",{"type":63,"coordinates":64},"Point",[65,66],14.42076,50.08804,{"lat":66,"lon":65},[69,72],{"name":70,"role":48,"phone":53,"phoneExt":12,"email":71},"Robert Zajíček, MD, PhD","robert.zajicek@fnkv.cz",{"name":73,"role":48,"phone":12,"phoneExt":12,"email":74},"Study coordinator","burnsec@fnkv.cz",{"type":76,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[78],{"name":79,"class":6},"Masaryk University","100626420","reduction-of-muscle-catabolism-through-brain-activation-in-burn-patients-100626420",false,"NCT07435402","Reduction of Muscle Catabolism Through Brain Activation in Burn Patients","Reduction of Muscle Catabolism Through Brain Activation in Burn Patients (REMBRANT)","REMBRANT","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Severe burn injury involving more than 30% of total body surface area (TBSA)\n* Admission to the intensive care unit\n* Expected need for invasive mechanical ventilation and continuous sedation for at least 7 days\n* Ability to obtain written informed consent from the patient or a legally authorized representative\n\nExclusion Criteria:\n\n* Pre-existing severe neuromuscular or neurodegenerative disease\n* Known contraindication to inhalational sedation with isoflurane\n* Pregnancy or breastfeeding\n* Participation in another interventional clinical trial that could interfere with the study outcomes\n* Any condition that, in the opinion of the investigator, would make participation in the study unsafe or interfere with protocol adherence","ALL","18 Years",{"count":91,"type":92},30,"ESTIMATED","INTERVENTIONAL",[95],"NA","Patients with extensive burn injuries frequently develop severe skeletal muscle wasting and weakness as part of critical illness-related myopathy and neuropathy. This condition delays ventilator weaning, prolongs intensive care unit (ICU) and hospital stay, and contributes to long-term functional impairment and reduced quality of life. In burn patients, muscle loss is particularly pronounced during the early post-injury phase and is associated with mitochondrial dysfunction and altered neuromuscular signaling.\n\nEffective strategies to prevent muscle catabolism in critically ill burn patients remain limited. Although early active rehabilitation is beneficial, many patients are unable to participate due to deep sedation, mechanical ventilation, or clinical instability. Therefore, innovative rehabilitation approaches applicable during the acute phase of critical illness are needed.\n\nThe REMBRANT (REduction of Muscle catabolism through BRAin activation in burn patieNTs) study is a single-center, randomized, controlled, open-label clinical trial evaluating whether a multimodal brain-activating rehabilitation strategy can attenuate skeletal muscle loss in adult patients with severe burns. Thirty patients with burns involving more than 30% of total body surface area who require invasive mechanical ventilation and prolonged sedation will be randomized in a 1:1 ratio to standard care or an intervention group.\n\nBoth groups will receive standardized burn treatment and conventional rehabilitation. The intervention group will additionally receive the Burn-Bundle Extended Rehabilitation Program, combining inhalational isoflurane sedation with functional proprioceptive stimulation, repetitive transcranial magnetic stimulation, and virtual reality-assisted rehabilitation when clinically feasible.\n\nThe primary outcome is change in skeletal muscle mass and strength. Secondary outcomes include ICU length of stay, ventilator-free days, mitochondrial function, and health-related quality of life.",[98,99,100],"Burns - Multiple","Critical Illness","Muscle Weakness",[102,103,104],"extensive burn injury","skeletal muscle wasting","brain activation","NOT_YET_RECRUITING","2026-02-21",{"date":108,"type":109},"2026-02-27","ACTUAL",{"date":111,"type":92},"2026-05-01",{"date":113,"type":92},"2030-06-30",{"name":5,"class":6},1]