Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-05 @ 6:01 AM
Study NCT ID:
NCT01922960
Status:
WITHDRAWN
Last Update Posted:
2017-11-29
First Post:
2013-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microcirculatory Assessment in Patients With Trauma and Severe Burns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}], 'ancestors': [{'id': 'D012769', 'term': 'Shock'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'investigators decided not to move forward with project', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-04-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-27', 'studyFirstSubmitDate': '2013-06-27', 'studyFirstSubmitQcDate': '2013-08-12', 'lastUpdatePostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dysfunctional capillary density correlates with development of multiple organ failure', 'timeFrame': 'approximately 1 year to assess outcome measure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['trauma', 'multiple organ dysfunction syndrome'], 'conditions': ['Burns', 'Trauma']}, 'descriptionModule': {'briefSummary': 'Predict the development of multiple organ failure in patients with trauma and severe burns.', 'detailedDescription': 'Microvascular alterations are frequently seen in patients with sepsis, trauma, burns and those who are hemodynamically uncompensated(Shock).\n\nThe use of the Microscan is a non-invasive approach to visualize and assess impaired mucosal microcirculation in order to identify early on patients who are predisposed for MOF (multiple organ failure)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with severe burns/trauma ages 19-80. Patients undergoing elective abdominal or cardiothoracic surgery ages 19-69 years old\n\nExclusion Criteria:\n\n* Patients undergoing elective surgery \\< 19 years old.'}, 'identificationModule': {'nctId': 'NCT01922960', 'briefTitle': 'Microcirculatory Assessment in Patients With Trauma and Severe Burns', 'organization': {'class': 'OTHER', 'fullName': 'University of South Alabama'}, 'officialTitle': 'Microcirculatory Assessment in Patients With Trauma and Severe Burns', 'orgStudyIdInfo': {'id': '12-092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'micro-imaging', 'description': 'Sublingual or subconjunctival micro-imaging of the microcirculation taken for 3 minute intervals at certain timepoints.\n\nTimepoints for burn/trauma subjects: Day0, Day1,Day2,Day6 \\& Day7 Timepoints for general surgery population: post-induction, prior to resection, after resection,\\& closing of surgical wound.', 'interventionNames': ['Other: micro-imaging']}], 'interventions': [{'name': 'micro-imaging', 'type': 'OTHER', 'description': 'micro-imaging', 'armGroupLabels': ['micro-imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36617', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama Medical Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}], 'overallOfficials': [{'name': 'William O Richards, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of South Alabama, Department of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Alabama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Chair and Principle Investigator', 'investigatorFullName': 'William Richards', 'investigatorAffiliation': 'University of South Alabama'}}}}