Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
Study NCT ID:
NCT00583206
Status:
WITHDRAWN
Last Update Posted:
2017-02-28
First Post:
2007-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Muscle Atrophy in Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D001247', 'term': 'Asthenia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Muscle RNA; blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-24', 'studyFirstSubmitDate': '2007-12-20', 'studyFirstSubmitQcDate': '2007-12-20', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electrical stimulation will be associated with upregulation of anabolic signaling molecules and genes, downregulation of catabolic signaling molecules and genes within skeletal muscle of patients with sepsis', 'timeFrame': '3 days'}], 'secondaryOutcomes': [{'measure': 'Electrical stimulation will be associated with improvement of histologic and electrophysiologic and strength parameters within skeletal muscle of patients with sepsis', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sepsis', 'atrophy', 'muscle', 'weakness'], 'conditions': ['Atrophy', 'Sepsis', 'Weakness']}, 'descriptionModule': {'briefSummary': 'Severe sepsis will provoke signals leading to muscle atrophy and weakness. Electrical stimulation will reduce the impact of sepsis.', 'detailedDescription': 'Hypothesis 1: Severe sepsis will be associated with downregulation of anabolic signaling molecules and genes, upregulation of catabolic signaling molecules and genes, and the development of histologic and electrophysiologic abnormalities within skeletal muscle.\n\nHypothesis 2: Electrical stimulation will improve muscle strength in patients with sepsis.\n\nHypothesis 3: Electrical stimulation will be associated with upregulation of anabolic signaling molecules and genes, downregulation of catabolic signaling molecules and genes, and improvement of histologic and electrophysiologic parameters within skeletal muscle of patients with sepsis.\n\nHypothesis 4: The ratio of catabolic:anabolic gene expression on Day 3 will be positively correlated with the severity of clinical weakness on Day 7'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Severe sepsis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe sepsis for \\< 72hr'}, 'identificationModule': {'nctId': 'NCT00583206', 'briefTitle': 'Muscle Atrophy in Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Biochemical Pathways to Skeletal Muscle Atrophy in Human Sepsis', 'orgStudyIdInfo': {'id': '200706755'}}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gregory A. Schmidt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gregory A. Schmidt', 'investigatorAffiliation': 'University of Iowa'}}}}