Nctid:
NCT06234826
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009133", "term"=>"Muscular Atrophy"}, {"id"=>"D000016638", "term"=>"Critical Illness"}], "ancestors"=>[{"id"=>"D000001284", "term"=>"Atrophy"}, {"id"=>"D000020763", "term"=>"Pathological Conditions, Anatomical"}, {"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000020879", "term"=>"Neuromuscular Manifestations"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M19010", "name"=>"Critical Illness", "asFound"=>"Critical Illness", "relevance"=>"HIGH"}, {"id"=>"M12090", "name"=>"Muscular Atrophy", "asFound"=>"Muscle Atrophy", "relevance"=>"HIGH"}, {"id"=>"M4589", "name"=>"Atrophy", "relevance"=>"LOW"}, {"id"=>"M21265", "name"=>"Wasting Syndrome", "relevance"=>"LOW"}, {"id"=>"M5363", "name"=>"Cachexia", "relevance"=>"LOW"}, {"id"=>"M22519", "name"=>"Pathological Conditions, Anatomical", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M22619", "name"=>"Neuromuscular Manifestations", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>20}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-04-17", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-04", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-30", "studyFirstSubmitDate"=>"2023-05-16", "studyFirstSubmitQcDate"=>"2024-01-30", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-04", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"muscle protein synthesis rate (%/h)", "timeFrame"=>"7 days of stay at the intensive care unit", "description"=>"obtained by using deuterated water, muscle biopsy sampling and blood sampling"}], "secondaryOutcomes"=>[{"measure"=>"skeletal muscle fiber characteristics 1", "timeFrame"=>"7 days of stay at the intensive care unit", "description"=>"cross sectional area of muscle fibers"}, {"measure"=>"skeletal muscle fiber characteristics 2", "timeFrame"=>"7 days of stay at the intensive care unit", "description"=>"amount and distribution of muscle fibers (distribution will be calculated as: amount of type X / total amount of fibres)"}, {"measure"=>"mRNA expression in skeletal muscle tissue 1", "timeFrame"=>"7 days of stay at the intensive care unit", "description"=>"mRNA expression in skeletal muscle tissue of MAFBx (atrophy marker)"}, {"measure"=>"mRNA expression in skeletal muscle tissue 2", "timeFrame"=>"7 days of stay at the intensive care unit", "description"=>"mRNA expression in skeletal muscle tissue of MurF1 (atrophy marker)"}, {"measure"=>"mRNA expression in skeletal muscle tissue 3", "timeFrame"=>"7 days of stay at the intensive care unit", "description"=>"mRNA expression in skeletal muscle tissue of FOXO (atrophy marker)"}, {"measure"=>"patient characteristic- age", "timeFrame"=>"7 days of stay at the intensive care unit", "description"=>"age in years"}, {"measure"=>"patient characteristic- body weight", "timeFrame"=>"7 days of stay at the intensive care unit", "description"=>"body weight in kg"}, {"measure"=>"patient characteristic- height", "timeFrame"=>"7 days of stay at the intensive care unit", "description"=>"height in m"}, {"measure"=>"patient characteristic- sex", "timeFrame"=>"7 days of stay at the intensive care unit", "description"=>"male or female"}, {"measure"=>"patient characteristics (medical1)", "timeFrame"=>"7 days of stay at the intensive care unit", "description"=>"mechanical ventilation (duration in days)"}, {"measure"=>"patient characteristics (medical2)", "timeFrame"=>"7 days of stay at the intensive care unit", "description"=>"comorbidities (list of comorbidities)"}, {"measure"=>"patient characteristics (medical3)", "timeFrame"=>"7 days of stay at the intensive care unit", "description"=>"reason hospital admission"}, {"measure"=>"patient characteristic- APACHE score II", "timeFrame"=>"7 days of stay at the intensive care unit", "description"=>"APACHE II score = acute physiology score + age points + chronic health points. Minimum score = 0; maximum score = 71."}, {"measure"=>"patient characteristic- food intake", "timeFrame"=>"7 days of stay at the intensive care unit", "description"=>"food intake (energy in kcal and protein intake in g/kg/d)"}, {"measure"=>"patient characteristic- LOS", "timeFrame"=>"Stay at the intensive care unit and Hospital (up to 1 year)", "description"=>"Length of stay ICU and hospital (in days)"}, {"measure"=>"muscle volume", "timeFrame"=>"3 months post-hospital discharge", "description"=>"3d ultrasound assessed at follow up visit"}, {"measure"=>"habitual food", "timeFrame"=>"3 months post-hospital discharge", "description"=>"Assessed using questionnaires at follow up visit (higher score means better intake)"}, {"measure"=>"habitual activity", "timeFrame"=>"3 months post-hospital discharge", "description"=>"Assessed using questionnaires at follow up visit (higher score means better intake)"}, {"measure"=>"muscle hand grip strength", "timeFrame"=>"3 months post-hospital discharge", "description"=>"hand grip strength using the JAMAR dynamometer in kg"}, {"measure"=>"leg muscle strength", "timeFrame"=>"3 months post-hospital discharge", "description"=>"1RM upper leg at follow up visit"}, {"measure"=>"Functional capacity 1", "timeFrame"=>"3 months post-hospital discharge", "description"=>"SPPB at follow up visit (short physical performance battery)"}, {"measure"=>"Functional capacity 2", "timeFrame"=>"3 months post-hospital discharge", "description"=>"6min walking test at follow up visit"}, {"measure"=>"Quality of life questionnaire", "timeFrame"=>"3 months post-hospital discharge", "description"=>"SF-36 at follow up visit (Short Form Health Survey 36 items) range score between 0-100, lower score represents great health related problems"}, {"measure"=>"Quality of life questionnaires", "timeFrame"=>"3 months post-hospital discharge", "description"=>"Euro-QoL-5D-5-level at follow up visit (Euro quality of life 5 Dimension 5 level) Answers can be converted into EQ-5D index, an utility scores anchored at 0 for death and 1 for perfect health"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Critical Illness", "Muscle Atrophy"]}, "descriptionModule"=>{"briefSummary"=>"Muscle wasting occurs rapidly in critically ill patients and impacts both short and long term outcomes. Altered protein metabolism drives muscle loss in ICU patients, with muscle protein breakdown exceeding muscle protein synthesis (MPS). Interventions aimed at attenuating muscle loss by stimulating MPS rates are hampered by a lack of knowledge on altered muscle protein turnover rates during critical illness. Only a few studies have specifically assessed muscle protein synthesis by using contemporary intravenous stable isotope infusions, which allows the assessment of MPS over a short (\\<9 hours) period of time. Results from such acute studies can be difficult to extend or translate into long-term clinical practice and outcomes. Oral deuterated water (2H2O) dosing provides an alternative method that can be utilized to extend the measurement of muscle protein synthesis over a period of several days or weeks. It could therefore provide a valuable tool to study muscle protein synthesis during ICU admission and the impact of different anabolic interventions. Although multiple studies using the deuterated water methodology have been performed in both healthy volunteers and patients, it has not yet been performed in critically ill patients.\n\nIn this prospective study the investigators aim to assess fractional rates of muscle protein synthesis over a period of (maximal) 7 days in critically ill patients admitted to the intensive care unit. Secondly, the investigators aim to assess mechanisms of acute muscle wasting on an microscopic, ultrastructural and molecular level. Furthermore, the investigators aim to investigate to what extent muscle fibre size is recovered 3 months after ICU discharge."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"90 years", "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"In total 20 patients admitted to the ICU will be included.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* age \\>18y\n* admitted to ICU\n* enteral nutrition line in situ\n* arterial line (any location) in situ\n* expected stay ICU \\>7d\n\nExclusion Criteria:\n\n* spinal cord injury\n* chronic use of corticosteroids before hospital admission\n* Contraindication to enteral infusion (e.g. due to GI-tract perforation)\n* Kidney or liver failure\n* therapeutic anti coagulation"}, "identificationModule"=>{"nctId"=>"NCT06234826", "acronym"=>"IC-MPS", "briefTitle"=>"Skeletal Muscle Wasting in ICU Patients", "organization"=>{"class"=>"OTHER", "fullName"=>"Hasselt University"}, "officialTitle"=>"Skeletal Muscle Wasting in ICU Patients", "orgStudyIdInfo"=>{"id"=>"2022/165"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"3500", "city"=>"Hasselt", "state"=>"Limburg", "status"=>"RECRUITING", "country"=>"Belgium", "contacts"=>[{"name"=>"Bjorn Stessel, PhD", "role"=>"CONTACT", "email"=>"bjorn.stessel@jessazh.be"}], "facility"=>"Jessa Hospital", "geoPoint"=>{"lat"=>50.93106, "lon"=>5.33781}}], "centralContacts"=>[{"name"=>"Michelle Weijzen, Dr.", "role"=>"CONTACT", "email"=>"michelle.weijzen@uhasselt.be", "phone"=>"003211268706"}, {"name"=>"Frank Vandenabeele, Prof.", "role"=>"CONTACT", "email"=>"frank.vandenabeele@uhasselt.be"}], "overallOfficials"=>[{"name"=>"Frank Vandenabeele, Prof.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Hasselt University"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Frank Vandenabeele", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Jessa Hospital", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"principal investigator", "investigatorFullName"=>"Frank Vandenabeele", "investigatorAffiliation"=>"Hasselt University"}}}}
