Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-27 @ 10:56 AM
Study NCT ID:
NCT04980092
Status:
RECRUITING
Last Update Posted:
2023-06-27
First Post:
2021-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Kidney Function and Osteomuscular Status After Critical Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-25', 'studyFirstSubmitDate': '2021-07-09', 'studyFirstSubmitQcDate': '2021-07-17', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measured GFR', 'timeFrame': 'between day 0 and day 7 after ICU discharge', 'description': 'plasma clearance of iohexol'}, {'measure': 'measured GFR', 'timeFrame': 'at 3 months after ICU discharge', 'description': 'plasma clearance of iohexol'}, {'measure': 'measured GFR', 'timeFrame': 'at 12 months after ICU discharge', 'description': 'plasma clearance of iohexol'}, {'measure': 'estimated GFR', 'timeFrame': 'between day 0 and day 7 after ICU discharge', 'description': 'cystatin C based CKD-EPI equation'}, {'measure': 'estimated GFR', 'timeFrame': 'at 3 months after ICU discharge', 'description': 'cystatin C based CKD-EPI equation'}, {'measure': 'estimated GFR', 'timeFrame': 'at 12 months after ICU discharge', 'description': 'cystatin C based CKD-EPI equation'}], 'secondaryOutcomes': [{'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'between day 0 and day 7 after ICU discharge', 'description': 'urine measurement of TGF-β concentration'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'at 3 months after ICU discharge', 'description': 'urine measurement of TGF-β concentration'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'at 12 months after ICU discharge', 'description': 'urine measurement of TGF-β concentration'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'between day 0 and day 7 after ICU discharge', 'description': 'urine measurement of monocyte chemoattractant protein-1 concentration'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'at 3 months after ICU discharge', 'description': 'urine measurement of monocyte chemoattractant protein-1 concentration'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'at 12 months after ICU discharge', 'description': 'urine measurement of monocyte chemoattractant protein-1 concentration'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'between day 0 and day 7 after ICU discharge', 'description': 'urine measurement of matrix metalloproteinases concentration'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'at 3 months after ICU discharge', 'description': 'urine measurement of matrix metalloproteinases concentration'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'at 12 months after ICU discharge', 'description': 'urine measurement of matrix metalloproteinases concentration'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'between day 0 and day 7 after ICU discharge', 'description': 'urine measurement of chemokine ligands concentration'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'at 3 months after ICU discharge', 'description': 'urine measurement of chemokine ligands concentration'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'at 12 months after ICU discharge', 'description': 'urine measurement of chemokine ligands concentration'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'between day 0 and day 7 after ICU discharge', 'description': 'urine measurement of C-X-C motif chemokine ligand concentration'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'at 3 months after ICU discharge', 'description': 'urine measurement of C-X-C motif chemokine ligand concentration'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'at 12 months after ICU discharge', 'description': 'urine measurement of C-X-C motif chemokine ligand concentration'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'between day 0 and day 7 after ICU discharge', 'description': 'measurement of proteinuria'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'at 3 months after ICU discharge', 'description': 'measurement of proteinuria'}, {'measure': 'urine concentration of renal fibrose biomarkers', 'timeFrame': 'at 12 months after ICU discharge', 'description': 'measurement of proteinuria'}, {'measure': 'blood concentration of muscle turnover markers', 'timeFrame': 'between day 0 and day 7 after ICU discharge', 'description': 'blood measurement of myostatin concentration'}, {'measure': 'blood concentration of muscle turnover markers', 'timeFrame': 'at 3 months after ICU discharge', 'description': 'blood measurement of myostatin concentration'}, {'measure': 'blood concentration of muscle turnover markers', 'timeFrame': 'at 12 months after ICU discharge', 'description': 'blood measurement of myostatin concentration'}, {'measure': 'blood concentration of muscle turnover markers', 'timeFrame': 'between day 0 and day 7 after ICU discharge', 'description': 'blood measurement of procollagen type III N-terminal peptide (P3NP) concentration'}, {'measure': 'blood concentration of muscle turnover markers', 'timeFrame': 'at 3 months after ICU discharge', 'description': 'blood measurement of procollagen type III N-terminal peptide (P3NP) concentration'}, {'measure': 'blood concentration of muscle turnover markers', 'timeFrame': 'at 12 months after ICU discharge', 'description': 'blood measurement of procollagen type III N-terminal peptide (P3NP) concentration'}, {'measure': 'blood concentration of muscle turnover markers', 'timeFrame': 'between day 0 and day 7 after ICU discharge', 'description': 'blood measurement of insulin growth factor 1 concentration'}, {'measure': 'blood concentration of muscle turnover markers', 'timeFrame': 'at 3 months after ICU discharge', 'description': 'blood measurement of insulin growth factor 1 concentration'}, {'measure': 'blood concentration of muscle turnover markers', 'timeFrame': 'at 12 months after ICU discharge', 'description': 'blood measurement of insulin growth factor 1 concentration'}, {'measure': 'bone micro-architecture', 'timeFrame': 'between day 0 and day 7 after ICU discharge', 'description': 'high resolution peripheral quantitative computed tomography (HRpQCT) images acquisition'}, {'measure': 'bone micro-architecture', 'timeFrame': 'at 3 months after ICU discharge', 'description': 'high resolution peripheral quantitative computed tomography (HRpQCT) images acquisition'}, {'measure': 'bone micro-architecture', 'timeFrame': 'at 12 months after ICU discharge', 'description': 'high resolution peripheral quantitative computed tomography (HRpQCT) images acquisition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Illness', 'Kidney Injury', 'Muscle Loss', 'Bone Loss']}, 'descriptionModule': {'briefSummary': 'This observational study aims to assess kidney function through direct glomerular filtration rate (GFR) using iohexol clearance, compared to estimated GFR based on creatinine and cystatin C equations. Kidney function will also be evaluated through renal fibrosis biomarkers. Kidney function will be correlated to body composition, muscle turnover biomarkers, and bone micro-architecture.', 'detailedDescription': 'The investigators developed a post-ICU clinic where complications of the post-intensive care syndrome are detected. Muscle function is assessed by clinical testings, muscle strength measurement. Body composition is measured by electrical bioimpedance. Bone mass is assessed using dual-energy radiographic absorptiometry.\n\nIt is well known that ICU survivors experience a loss of muscle mass. This can lead to misinterpretation of estimated GFR based on creatinine equations.\n\nThe aim of the present study is to assess the evolution of kidney function after a prolonged stay in ICU, using GFR equations based on cystatin C, and to compare it to measured GFR using iohexol clearance.\n\nThe second aim is to explore the evolution of bone and muscle health in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'survivors of an ICU stay of at least 7 days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients surviving an ICU stay of at least 7 days\n* patients who experienced acute kidney injury (KDIGO criteria) during ICU stay\n\nExclusion Criteria:\n\n* chronic kidney injury with dedicated follow-up before ICU admission\n* chronic extrarenal epuration\n* kidney transplant\n* allergy to iohexol\n* iodinated contrast allergy\n* refusal'}, 'identificationModule': {'nctId': 'NCT04980092', 'briefTitle': 'Assessment of Kidney Function and Osteomuscular Status After Critical Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Assessment of Kidney Function and Osteomuscular Status in Survivors of a Prolonged Stay in Intensive Care Unit', 'orgStudyIdInfo': {'id': 'ROPS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Post-ICU group', 'description': 'Observational foolow-up', 'interventionNames': ['Other: one-year follow-up']}], 'interventions': [{'name': 'one-year follow-up', 'type': 'OTHER', 'description': 'patients will be followed during the year after ICU discharge, in order to assess kidney function, and muscle and bone health', 'armGroupLabels': ['Post-ICU group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Anne-Françoise Rousseau, PhD', 'role': 'CONTACT', 'email': 'afrousseau@chuliege.be', 'phone': '+3243667495'}], 'facility': 'University Hospital of Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'Anne-Françoise Rousseau, MD, PhD', 'role': 'CONTACT', 'email': 'afrousseau@chuliege.be', 'phone': '+3243667495'}], 'overallOfficials': [{'name': 'Anne-Françoise Rousseau, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital of Liège'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Clinic', 'investigatorFullName': 'Anne-Françoise Rousseau', 'investigatorAffiliation': 'University of Liege'}}}}