[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509938":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":41,"locations":49,"responsibleParty":112,"collaborators":115,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":20,"eligibilityCriteria":132,"healthyVolunteers":128,"sex":133,"minAge":134,"maxAge":20,"enrollmentInfo":135,"targetDuration":20,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":149,"overallStatus":52,"whyStopped":20,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Technical University of Munich","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","High protein substitution plus NMES and EM",[13,14,15],"Dietary Supplement: Dietary Supplement: additional substitution of protein","Device: Neuromuscular electrical stimulation","Other: Early Mobilization",{"label":17,"type":18,"description":19,"interventionNames":20},"Control Group","NO_INTERVENTION","Nutrition and mobilization are carried out according to standard of care.",null,[22,27,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":20},"DIETARY_SUPPLEMENT","Dietary Supplement: additional substitution of protein","Day one (admission) no nutrition is applied.\n\nProtein target is increased as follows:\n\n* to a level of 1,2g\u002Fkg\u002Fd on day 1 after ICU admission\n* to a level of 1,4g\u002Fkg\u002Fd on day 2 after ICU admission\n* to a level of 1,6g\u002Fkg\u002Fd on day 3 after ICU admission\n* to a level of 1,8g\u002Fkg\u002Fd on day 4 after ICU admission\n* to a level of 2,0g\u002Fkg\u002Fd from day 5 onwoards\n\nAdditional protein is given within 2 hours after mobilization respectively:\n\n* to 0,125g\u002Fkg\u002Fd on day 1 after ICU admission\n* to 0,2g\u002Fkg\u002Fd on day 2 after ICU admission\n* to 0,25g\u002Fkg\u002Fd on day 3 after ICU admission\n* to 0,3g\u002Fkg\u002Fd from day 4 after ICU admission onwoards",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":20},"DEVICE","Neuromuscular electrical stimulation","twice daily 60 minutes till day 28 or ICU discharge",[9],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":20},"Early Mobilization","at least 20 minutes a day following the SOMS concept. Duration: till 28 day or ICU discharge",[9],[37],{"name":38,"affiliation":39,"role":40},"Stefan J Schaller, MD","Medical University of Vienna & Charité - Universitätsmedizin Berlin","PRINCIPAL_INVESTIGATOR",[42,46],{"name":38,"role":43,"phone":44,"phoneExt":20,"email":45},"CONTACT","+498941409635","s.schaller@tum.de",{"name":47,"role":43,"phone":20,"phoneExt":20,"email":48},"Marian Demitsch","aai-research@muv.ac.at",[50,72,85,95],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Medical University of Vienna","RECRUITING","Vienna","State of Vienna","1090","Austria","AT",{"type":59,"coordinates":60},"Point",[61,62],16.37208,48.20849,{"lat":62,"lon":61},[65,68,71],{"name":38,"role":43,"phone":66,"phoneExt":20,"email":67},"+4314040041020","stefan.schaller@meduniwien.ac.at",{"name":69,"role":43,"phone":66,"phoneExt":20,"email":70},"Study Coordinator","aai-research@meduniwien.ac.at",{"name":38,"role":40,"phone":20,"phoneExt":20,"email":20},{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":84,"contacts":20},"Klinikum rechts der Isar, School of Medicine, Technical Universtity of Munich","ACTIVE_NOT_RECRUITING","Munich","Bavaria","81675","Germany","DE",{"type":59,"coordinates":81},[82,83],11.57549,48.13743,{"lat":83,"lon":82},{"facility":86,"status":74,"city":87,"state":88,"zip":89,"country":78,"countryCode":79,"cosmosGeoPoint":90,"geoPoint":94,"contacts":20},"Charité - Universitätsmedizin Berlin","Berlin","State of Berlin","10117",{"type":59,"coordinates":91},[92,93],13.41053,52.52437,{"lat":93,"lon":92},{"facility":96,"status":52,"city":97,"state":20,"zip":98,"country":78,"countryCode":79,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Universitätsklinikum Ulm","Ulm","89070",{"type":59,"coordinates":100},[101,102],9.99155,48.39841,{"lat":102,"lon":101},[105,108,111],{"name":106,"role":43,"phone":20,"phoneExt":20,"email":107},"Flora Scheffenbichler, MD","flora.scheffenbichler@uni-ulm.de",{"name":109,"role":43,"phone":20,"phoneExt":20,"email":110},"Bettina Jungwirth, MD","ains@uniklinik- ulm.de",{"name":106,"role":40,"phone":20,"phoneExt":20,"email":20},{"type":40,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":51,"oldNameTitle":20,"oldOrganization":20},"Prof. Dr. Stefan Schaller, MD","Full Professor",[116,119,121,123,125],{"name":117,"class":118},"Fresenius Kabi","INDUSTRY",{"name":120,"class":6},"University Medicine Greifswald",{"name":122,"class":6},"Berlin Institute of Health",{"name":96,"class":124},"UNKNOWN",{"name":51,"class":6},"100509938","improved-muscle-metabolism-by-combination-of-muscle-activation-and-protein-substitution--imempro--100509938",false,"NCT05919940","Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution ( IMEMPRO )","Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution: a Randomized, Outcome-assessor Blinded, Proof-of-concept Study (IMEMPRO)","Inclusion Criteria:\n\n* critically ill adults (≥ 18 years of age)\n* newly admitted to the ICU (\\\u003C48h)\n* mechanically ventilated, expected to remain for at least 72h\n* enteral nutrition is feasible\n\nExclusion Criteria:\n\n* a BMI \\> 30\n* expected death or withdrawal of life-sustaining treatments\n* prior neuromuscular disease (e.g. paresis, myopathies, neuropathies)\n* injury or disease preventing neuromuscular electrical stimulation or early mobilization (e.g., elevated intracranial pressure, unstable spine)\n* a pacemaker or other electronic implant\n* allergy to components of NMES adhesive\n* have been dependent during activities of daily living prior to the hospital admission\n* a language barrier","ALL","18 Years",{"count":136,"type":137},40,"ESTIMATED","INTERVENTIONAL",[140],"NA","Intensive Care Unit Acquired Weakness (ICUAW) describes muscle weakness that occurs in around 40% of patients during an intensive care stay. The morbidity and mortality of these patients is significantly increased over a 5-year period. The aim of this study is to investigate the combined effect of early enteral high-protein nutrition and early muscle activation on muscle atrophy in critically ill patients.\n\nThe study will include 40 patients (20 intervention, 20 observation) with requirement for enteral nutrition at time of inclusion. In the intervention group the maximum possible level of mobilization is carried out and muscles are activated twice a day using neuromuscular electrical stimulation (NMES). The nutrition plan of the intervention group is based on the applicable guidelines for intensive care medicine with exception of increased protein intake. The control group receives therapy without deviating from the standard according of the DGEM guideline.\n\nThe study aims to show that the decrease in muscle mass is significantly less than in the control group (primary hypothesis) via ultrasound of the rectus femoris muscle and in case of given consent muscle biopsy. As secondary hypothesis it is examined whether the combination of early high protein intake and muscle activation improves muscle strength and endurance.",[143,144,145,146,147,148],"ICU Acquired Weakness","Muscle Atrophy","Energy Malnutrition Protein","Quality of Life","Morphological and Microscopic Findings","Metabolic Disturbance",[150],"Early Mobilization and high-protein nutrition","2026-02-28",{"date":153,"type":154},"2026-03-03","ACTUAL",{"date":156,"type":154},"2023-06-27",{"date":158,"type":137},"2027-01-31",{"name":5,"class":6},4]