Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-05 @ 5:41 PM
Study NCT ID:
NCT02111018
Status:
WITHDRAWN
Last Update Posted:
2023-04-07
First Post:
2014-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients With Rhabdomyolysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012206', 'term': 'Rhabdomyolysis'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2014-03-19', 'studyFirstSubmitQcDate': '2014-04-07', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of device as measured by change in myoglobin', 'timeFrame': '30 days'}, {'measure': 'Assessment of serious device or procedure-related adverse events', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rhabdomyolysis']}, 'descriptionModule': {'briefSummary': 'Prospective, randomized non-blinded, controlled study to assess the feasibility of the CytoSorb as an adjunct to the standard of care in patients with rhabdomyolysis requiring renal replacement therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is age 18-80\n* Subjects present with rhabdomyolysis\n* Subject requires renal replacement therapy and has undergone adequate volume resuscitation\n* Subject is willing to comply with specified follow up requirements\n\nExclusion Criteria:\n\n* Subject or their legal guardian either declines or cannot give informed consent\n* Subject is pregnant\n* Subject has been previously enrolled in this clinical study\n* Comorbid condition that may limit survival to ≤14 days\n* Comorbid condition that could confound study results\n* Subjects who are receiving immunosuppressive therapy'}, 'identificationModule': {'nctId': 'NCT02111018', 'briefTitle': 'Extracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients With Rhabdomyolysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'CytoSorbents, Inc'}, 'orgStudyIdInfo': {'id': 'CytoSorb 2013-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CVVH', 'interventionNames': ['Procedure: CVVH']}, {'type': 'EXPERIMENTAL', 'label': 'CytoSorb Device', 'interventionNames': ['Device: CytoSorb Device']}], 'interventions': [{'name': 'CytoSorb Device', 'type': 'DEVICE', 'armGroupLabels': ['CytoSorb Device']}, {'name': 'CVVH', 'type': 'PROCEDURE', 'armGroupLabels': ['CVVH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78234', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Military Medical Center- US Army Institute of Surgical Research- Burn Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'LTC Kevin Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Antonio Military Medical Center-US Army Institute of Surgical Research-Burn Center'}, {'name': 'MAJ Ian Stewart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Antonio Military Medical Center-US Army Institute of Surgical Research- Burn Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CytoSorbents, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'San Antonio Military Medical Center (SAMMC), US Army Institute of Surgical Research-Burn Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}