Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-04 @ 4:11 PM
Study NCT ID:
NCT03810768
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2018-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Blood\n* Skeletal muscle biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-14', 'studyFirstSubmitDate': '2018-12-25', 'studyFirstSubmitQcDate': '2019-01-16', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Identify possible predictors of muscle wasting in the blood metabolome preoperatively', 'timeFrame': 'a median of 14 days', 'description': 'Among the blood metabolome that will be measured, identify metabolites or combinations of metabolites whose high or low concentration(s) preoperatively associate(s) with the amount of muscle loss. These metabolites are candidate biomarkers that could be used to identify individuals at risk of large muscle wasting and may give further insights into the mechanisms of muscle wasting.'}, {'measure': 'Identify possible predictors of muscle wasting in the blood metabolome at ICU admission', 'timeFrame': 'a median of 14 days', 'description': 'Among the blood metabolome that will be measured, identify metabolites or combinations of metabolites whose high or low concentration(s) at ICU admission associate(s) with the amount of muscle loss. These metabolites are candidate biomarkers that could be used to identify individuals at risk of large muscle wasting and may give further insights into the mechanisms of muscle wasting.'}], 'primaryOutcomes': [{'measure': 'Metabolomics', 'timeFrame': 'a median of 14 days', 'description': 'Blood Metabolome will be isolated from blood samples. All samples will be screened for influence of Intensive Care Unit Acquired Weakness (ICUAW) using mass spectrometry.'}], 'secondaryOutcomes': [{'measure': 'Muscle histology', 'timeFrame': 'a median of 14 days', 'description': 'Immunohistochemistry will be done in muscle samples. All samples will be screened for influence of Intensive Care Unit Acquired Weakness (ICUAW) and correlation with blood metabolome changes.'}, {'measure': 'Phosphoproteomics', 'timeFrame': 'a median of 14 days', 'description': 'Phosphoproteomics will be done in muscle samples using mass spectrometry. All samples will be screened for influence of Intensive Care Unit Acquired Weakness (ICUAW) and correlation with blood metabolome changes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pilot trial', 'muscle biopsy', 'blood metabolome'], 'conditions': ['Metabolomics', 'Critical Care', 'Critical Illness', 'Critical Illness Myopathy', 'Critical Illness Polyneuropathy', 'Intensive Care (ICU) Myopathy', 'Muscle Weakness']}, 'descriptionModule': {'briefSummary': 'In this mono-center pilot trial, surgical patients who are at high risk to be admitted to intensive care will be screened and asked for participation. We are going to take blood and muscle samples at respecified time points to do metabolic, histological and molecular testing.\n\nAim of the study is to investigate (1) changes of the blood metabolome in patients with ICUAW (intensive care unit acquired weakness) and (2) identify metabolic components who are responsible for ICUAW or can be used as marker for ICUAW.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'mechanically ventilated postoperative high-risk patients who are admitted to intensive care', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* invasive mechanically ventilated critically ill patient with expected intensive care unit stay \\> 3 days\n* postoperative patient\n* ≥ 18 years old\n* American Society of Anesthesiology (ASA) classification ≥ III\n\nExclusion Criteria:\n\n* moribund patient\n* non-curative care (comfort care)'}, 'identificationModule': {'nctId': 'NCT03810768', 'acronym': 'MIRACLE I', 'briefTitle': 'Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Metabolomics Pilot Study on Postoperative Intensive Care Acquired Muscle Weakness (MIRACLE-I Study)', 'orgStudyIdInfo': {'id': 'MIRACLE I'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intensive Care Patients', 'description': 'Postoperative high-risk patients who have been admitted to intensive care after surgery'}, {'label': 'Operative Control patients', 'description': 'Elective operative patients where control blood samples and muscle ultrasound will be measured.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Stefan J Schaller, MD', 'role': 'CONTACT', 'email': 'stefan.schaller@meduniwien.ac.at', 'phone': '+4314040041020'}, {'name': 'Stefan Study Coordinator', 'role': 'CONTACT', 'email': 'aai-research@meduniwien.ac.at', 'phone': '+4314040041020'}, {'name': 'Stefan J Schaller, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar, School of Medicine, Technical University of Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan J Schaller, MD', 'role': 'CONTACT', 'email': 'stefan.schaller@charite.de', 'phone': '+49-30-450-531052'}], 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Stefan J Schaller, MD', 'role': 'CONTACT', 'email': 's.schaller@tum.de', 'phone': '+49-89-4140-9635'}, {'name': 'Manfred Blobner, MD', 'role': 'CONTACT', 'email': 'm.blobner@tum.de', 'phone': '+49-89-4140-7206'}], 'overallOfficials': [{'name': 'Stefan J Schaller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technical University of Munich'}, {'name': 'Hennig Wackerhage, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technical University of Munich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helmholtz Zentrum München', 'class': 'INDUSTRY'}, {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, {'name': 'Medical University of Vienna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prof. Dr. Stefan Schaller, MD', 'investigatorAffiliation': 'Medical University of Vienna'}}}}