Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT01321320
Status:
COMPLETED
Last Update Posted:
2013-10-17
First Post:
2011-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of the Role of FHL-1 and Myostatin in Intensive Care Unit Acquired Paresis (ICUAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-03-04', 'releaseDate': '2016-02-08'}, {'releaseDate': '2016-08-16', 'unreleaseDateUnknown': True}, {'resetDate': '2017-01-09', 'releaseDate': '2016-11-10'}, {'resetDate': '2019-09-12', 'releaseDate': '2019-08-07'}], 'estimatedResultsFirstSubmitDate': '2016-02-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'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': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-16', 'studyFirstSubmitDate': '2011-03-22', 'studyFirstSubmitQcDate': '2011-03-22', 'lastUpdatePostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in muscle myostatin and FHL-1', 'timeFrame': '1 week'}], 'secondaryOutcomes': [{'measure': 'Change in quadriceps cross sectional area', 'timeFrame': '1 week'}, {'measure': 'Change in quadriceps strength', 'timeFrame': '1 week'}, {'measure': 'Change in blood myostatin, miRNA and other markers of muscle breakdown', 'timeFrame': '1 week'}, {'measure': 'Changes in muscle protein synthesis and breakdown pathways as measured in the muscle biopsy samples.', 'timeFrame': '1 week'}, {'measure': 'Change in muscle breakdown and synthesis pathways as a factor of amount of muscle stimulation received.', 'timeFrame': '1 week'}, {'measure': 'Change in muscle phenotype and change in cross sectional area for individual fiber types', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ICUAP', 'Critical illness', 'Muscle wasting', 'ICU'], 'conditions': ['Intensive Care Unit Acquired Paresis', 'Muscle Wasting']}, 'descriptionModule': {'briefSummary': 'The primary hypothesis for this study is that Myostatin and FHL-1 are important in the development of ICUAP and that changes in activity levels of muscle will modify the levels of expression and activity of these proteins.', 'detailedDescription': 'ICUAP is an increasingly recognised clinical problem associated with significant morbidity and mortality. However the pathogenesis of the diseae is poorly understood and as yet no treatment exists. We believe that both myostatin and FHL-1 will be important in the development of this disease. This is based recent research and that both these proteins are likely to be regulated by sepsis and immobility (two major risk factors for ICUAP. There is evidence from invitro work that the two are likely to interact. We have designed an interventional trial to investigate the above hypothesis. Patients admitted to ICU and at risk of developing muscle wasting will be selected and receive electrical muscle stimulation of the quadriceps muscle for 1 week. Physiological measurements of peripheral and respiratory muscle strength and quadriceps size will be made pre and post intervention. And muscle biopsies, blood and urine collected from both legs pre and post intervention. The relevant molecular pathways can then be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High risk patients admitted to AICU.\n\nExclusion Criteria:\n\n* Pre existing neuromuscular disease.'}, 'identificationModule': {'nctId': 'NCT01321320', 'briefTitle': 'Investigation of the Role of FHL-1 and Myostatin in Intensive Care Unit Acquired Paresis (ICUAP)', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Investigation of the Role of FHL-1 and Myostatin in the Development of Intensive Care Unit Acquired Paresis (ICUAP) and the Effect of Increased Muscle Activity on These Pathways.', 'orgStudyIdInfo': {'id': 'CRO1439'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active stimulation', 'description': 'This group will receive active muscle stimulation for 1 week to the quadriceps muscle - the leg will be randomly assigned.', 'interventionNames': ['Other: Active muscle stimulation']}], 'interventions': [{'name': 'Active muscle stimulation', 'type': 'OTHER', 'description': 'Neuromuscular Electrical stimulation will be applied to one leg (randomly assigned).', 'armGroupLabels': ['Active stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'National Heart and Lung Institute, Imperial College', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'M Polkey', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Brompton Hospital and Imperial College'}, {'name': 'Susannah Bloch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Research Council', 'class': 'OTHER_GOV'}, {'name': 'Royal Brompton & Harefield NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Prof M Polkey', 'oldOrganization': 'Imperial College London and Royal Brompton Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-02-08', 'type': 'RELEASE'}, {'date': '2016-03-04', 'type': 'RESET'}, {'date': '2016-08-16', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2016-11-10', 'type': 'RELEASE'}, {'date': '2017-01-09', 'type': 'RESET'}, {'date': '2019-08-07', 'type': 'RELEASE'}, {'date': '2019-09-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Imperial College London'}}}}