Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-02-20 @ 6:42 PM
Study NCT ID:
NCT01890395
Status:
UNKNOWN
Last Update Posted:
2018-08-17
First Post:
2013-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioenergetics in Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-15', 'studyFirstSubmitDate': '2013-06-26', 'studyFirstSubmitQcDate': '2013-06-26', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation mitochondrial damps (mDAMPS) and multiple organ system failure', 'timeFrame': '1 year', 'description': 'Preliminary studies (at University of South Alabama)in the trauma and burn patients indicate that the level of mitochondrial damps are highly correlated with non-survival; that is, they reflect a massive trauma. They also reflect patients that have a propensity to go into multiple system organ failure. We believe that these measurements in our surgical patients will also reveal many of the same correlations with the correlation between microvascular circulation and the mitochondrial damps.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mitochondrial DAMPS'], 'conditions': ['Mitochondrial DAMP Levels in Surgical Patients']}, 'descriptionModule': {'briefSummary': 'To identify patients who may be predisposed for developing MOF (multiple organ failure)by the sampling of blood.', 'detailedDescription': 'The rationale for doing this study is the recognition that mitochondrial DNA Damage Associated Molecular Patterns (mtDAMPs) accumulate in the circulation after severe injury. Furthermore our own studies in severely injured patients identify that the mtDAMPS are increased 3-28 fold in those patients who eventually develop multiple organ dysfunction syndrome (MODS) compared to those severely traumatized patients who did not develop MODS. The relative risk of death from MODS after severe trauma was increased 8-20 times in those patients with elevated mt DAMP levels.\n\nThis study is then being done to correlate mitochondrial damp levels in surgical trauma to assess the time course and the levels of mtDAMPs with the type of surgical procedure. We believe that this information will help us to determine the time course of events and the triggers for development of multiple organ dysfunction seen after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients @ USAMC undergoing surgical operations expected to have microcirculatory changes, i.e., CABG, open heart, aortic or other revascularizing operations, general surgical operations such as colon resections, bowel resections or any other surgical procedures in which the subject could be expected to or might develop multiple system organ failure.\n\nExclusion Criteria:\n\nN/A'}, 'identificationModule': {'nctId': 'NCT01890395', 'briefTitle': 'Bioenergetics in Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of South Alabama'}, 'officialTitle': 'Bioenergetics in Surgical Patients', 'orgStudyIdInfo': {'id': '12-294'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'blood collection', 'description': 'procedure: Blood draws as the intervention', 'interventionNames': ['Other: Blood draws']}], 'interventions': [{'name': 'Blood draws', 'type': 'OTHER', 'description': 'Blood sampling collected at 9 timepoints: pre-operative, during surgery X 3, immediately after surgery, 24 hrs post-op, 72 hrs post-op, 5 days and 7 days post', 'armGroupLabels': ['blood collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36617', 'city': 'Mobile', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William O. Richards, MD', 'role': 'CONTACT', 'email': 'brichards@usouthal.edu', 'phone': '251-471-7993'}, {'name': 'William O. Richards, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jon Simmons, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mark Gillespie, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marcus Tan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of South Alabama Medical Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}], 'centralContacts': [{'name': 'William O. Richards, MD', 'role': 'CONTACT', 'email': 'brichards@usouthal.edu', 'phone': '251-471-7993'}], 'overallOfficials': [{'name': 'William O. Richards, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Alabama, Department of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Alabama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'William Richards', 'investigatorAffiliation': 'University of South Alabama'}}}}