[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626079":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":31,"centralContacts":45,"locations":51,"responsibleParty":64,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":31,"enrollmentInfo":81,"targetDuration":31,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":54,"whyStopped":31,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Wageningen University","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","SHAM_COMPARATOR","Sham-NMES with standard enteral nutrition",[13,14],"Other: Sham (No Treatment)","Other: Standard enteral nutrition",{"label":16,"type":17,"description":18,"interventionNames":19},"Whole-body NMES group","ACTIVE_COMPARATOR","Whole-body NMES stimulation with standard enteral nutrition",[20,14],"Other: NMES",{"label":22,"type":17,"description":23,"interventionNames":24},"Whole-body NMES + protein group","Whole-body NMES followed by a 20g amino acid bolus on top of the standard nutrition",[20,25,14],"Dietary Supplement: Amino acid bolus (20g)",[27,32,36,41],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Sham (No Treatment)","A placebo treatment in which no actual electrical stimulation is delivered, serving as a control for the active NMES.",[9],null,{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"NMES","Active neuromuscular electrical stimulation applied to the entire body to induce muscle contractions through small electric currents.",[22,16],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"DIETARY_SUPPLEMENT","Amino acid bolus (20g)","A bolus dose of 20 grams of amino acids provided after the NMES intervention to assess the combined effect of muscle stimulation and protein intake on muscle protein metabolism.",[22],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":31},"Standard enteral nutrition","The provision of standard nutritional support, typically administered via enteral feeding tubes.",[9,22,16],[46],{"name":47,"role":48,"phone":49,"phoneExt":31,"email":50},"Marlou Dirks, PhD","CONTACT","+31 317 480 100","marlou.dirks@wur.nl",[52],{"facility":53,"status":54,"city":55,"state":31,"zip":31,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":31},"Hospital Gelderse Vallei","RECRUITING","Ede","Netherlands","NL",{"type":59,"coordinates":60},"Point",[61,62],5.65833,52.03333,{"lat":62,"lon":61},{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Marlou Dirks","Associate Professor",[69],{"name":70,"class":6},"Gelderse Vallei Hospital","100626079","the-effect-of-muscle-stimulation-and-amino-acid-intake-on-protein-metabolism-during-critical-illness-100626079",false,"NCT07430969","The Effect of Muscle Stimulation and Amino Acid Intake on Protein Metabolism During Critical Illness","The Effect of a Single Session of Whole-body Neuromuscular Electrical Stimulation (NMES), With or Without Subsequent Intake of an Amino Acid Bolus, on Whole-body Protein Turnover in Sedated Intensive Care Unit (ICU) Patients","SPICE I","Inclusion Criteria:\n\n* Aged ≥18 years\n* Expected to need mechanical ventilation for at least 48 hours, judged by physician\n* Expected to reach a Richmond Agitation-Sedation Scale (RASS) score of -4 or -5 (complete sedation), judged by physician\n* Informed consent obtained from the next-of-kin\n* Able to or are receiving gastric tube feeding\n* Have an arterial and a venous line in situ\n\nExclusion Criteria:\n\n* Spinal cord injury\n* Previous surgery\u002Flocal wounds that prohibit whole-body NMES\n* Conditions that prohibit NMES (such open wounds)\n* Chronic neuromuscular disorders (such as Amyotrophic lateral sclerosis (ALS))\n* Acute Kidney Injury (AKI) II and III\n* Undergoing continuous veno-venous hemofiltration (CVVH)\n* Rhabdomyolysis\n* Neuromuscular blocking agents\n* In the caloric restriction period of refeeding syndrome\n* In prone position\n* Burn wounds\n* ICD\u002Fpacemaker\n* Pregnant\n* Deemed not suitable to participate based upon the judgement of the treating intensivist","ALL","18 Years",{"count":82,"type":83},30,"ESTIMATED","INTERVENTIONAL",[86],"NA","The goal of this clinical trial is to study how whole-body electrical stimulation combined with amino acid intake affects muscle health in ventilated ICU patients. The main questions to answer are:\n\n* Does electrostimulation improve the balance of muscle protein in ICU patients?\n* Does combining electrostimulation with amino acid help build muscle and prevent muscle loss?\n\nResearchers will compare three groups of patients:\n\n1. Sham electrostimulation (no current applied) + the standard nutrition\n2. Electrostimulation + the standard nutrition\n3. Electrostimulation + a 20g amino acid bolus\n\nParticipants will:\n\n* Receive either real or sham electrostimulation\n* Get their standard nutrition or a 20g amino acid bolus\n* Have marked amino acids given through an IV\n* Have blood samples taken to measure the amino acids and glucose in the blood\n* Undergo ultrasound of the upper arm to measure the blood flow",[89],"Muscle Wasting in Critically Ill",[33,91,92,93],"Skeletal Muscle Metabolism","Protein","ICU","2026-07-01",{"date":96,"type":97},"2026-07-02","ACTUAL",{"date":99,"type":83},"2026-07-18",{"date":101,"type":83},"2027-12",{"name":5,"class":6},1]