Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-03-01 @ 3:41 AM
Study NCT ID:
NCT03819959
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2019-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolomics Study on Intensive Care Acquired Muscle Weakness in Polytrauma
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': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-04', 'studyFirstSubmitDate': '2019-01-19', 'studyFirstSubmitQcDate': '2019-01-24', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Identify possible predictors of muscle wasting in the blood metabolome at ICU admission', 'timeFrame': 'a median of 14 days', 'description': '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 changes in the blood metabolome during muscle wasting (i.e. Intensive Care Unit Acquired Weakness) 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 changes in the muscular structure 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 muscular changes (i.e. Intensive Care Unit Acquired Weakness (ICUAW)) and correlation with blood metabolome changes.'}]}, 'oversightModule': {'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, polytrauma patients admitted to intensive care will be included. Investigators 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': 'polytrauma patients who are admitted to intensive care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute polytrauma patient\n* age ≥ 18 years old\n* expected intensive care stay ≥ 3 days\n* American Society of Anesthesiologists classification I or II\n\nExclusion Criteria:\n\n* patient had received cardiopulmonary resuscitation\n* limitation of therapy or comfort care'}, 'identificationModule': {'nctId': 'NCT03819959', 'acronym': 'MIRACLE II', 'briefTitle': 'Metabolomics Study on Intensive Care Acquired Muscle Weakness in Polytrauma', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Metabolomics Pilot Study on Intensive Care Acquired Muscle Weakness in Polytrauma (MIRACLE-II Study)', 'orgStudyIdInfo': {'id': 'MIRACLE II'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intensive Care Patients', 'description': 'Polytrauma patients who have been admitted to intensive care'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar, School of Medicine, Technical University of Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Stefan J Schaller, MD, MHBA', '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'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stefan Schaller', 'investigatorAffiliation': 'Technical University of Munich'}}}}