Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-01-28 @ 7:22 PM
Study NCT ID:
NCT02386202
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2015-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ARC in Hemorrhagic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083302', 'term': 'Hemorrhagic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2015-03-05', 'studyFirstSubmitQcDate': '2015-03-10', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe the onset, magnitude, and change over time of ARC in patients with hemorrhagic stroke', 'timeFrame': 'Over neurosciences intensive care unit stay', 'description': 'Daily 8-hour urine collections will be performed to directly measure creatinine clearance up to ICU discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemorrhagic Stroke', 'Augmented Renal Clearance']}, 'descriptionModule': {'briefSummary': 'To determine the incidence and predictors of augmented renal clearance (ARC) in patients with hemorrhagic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '30 patients with hemorrhagic stroke admitted to the University of North Carolina Neurosciences Intensive Care Unit', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults ≥ 18 years\n* Patients with hemorrhagic stroke\n* Anticipated length of stay in the neuroscience intensive care unit \\> 48 hours\n* Informed consent provided by the patient or by the patient's designated medical proxy\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients with pre-existing renal dysfunction (chronic kidney disease stages 3 - 5)\n* Patients receiving renal replacement therapy\n* Patients with an admission serum creatinine \\> 1.4 mg/dL\n* Patients with non-aneurysmal subarachnoid hemorrhage\n* Patients with history of nephrectomy or body mass index \\< 18 kg/m2"}, 'identificationModule': {'nctId': 'NCT02386202', 'briefTitle': 'ARC in Hemorrhagic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Augmented Renal Clearance in Hemorrhagic Stroke Patients Admitted to the Neurosciences Intensive Care Unit', 'orgStudyIdInfo': {'id': '14-1491'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with hemorrhagic stroke', 'description': 'All patients with hemorrhagic stroke admitted to the neurosciences ICU are eligible for study enrollment.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No interventions', 'armGroupLabels': ['Patients with hemorrhagic stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Hospitals', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Kathryn A Morbitzer, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Eshelman School of Pharmacy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}