Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-02-25 @ 10:03 PM
Study NCT ID:
NCT03622632
Status:
UNKNOWN
Last Update Posted:
2020-02-18
First Post:
2018-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-16', 'studyFirstSubmitDate': '2018-07-24', 'studyFirstSubmitQcDate': '2018-08-07', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of serial plasmatic uric acid sampling after trauma', 'timeFrame': '7 days', 'description': 'Number of measures collected/number of measures planned'}], 'secondaryOutcomes': [{'measure': 'Impact of resuscitation on uric acid measures', 'timeFrame': '24 to 48 hours', 'description': 'Impact of fluid administration (amount in mL) on the changes of subsequent uric acid blood level'}, {'measure': 'Clinical predictors of the first blood uric acid (μmol/L) level measured', 'timeFrame': '12 hours', 'description': "Impact of patient's characteristics and physiological variables on the first measured blood uric acid.\n\nCharacteristics will include: age (years), gender, Injury severity score, presence of acute renal impairment.\n\nPhysiological variables will include: lower systolic blood pressure, base deficit, lactate level"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['uric acid', 'organ failure'], 'conditions': ['Trauma', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'The goal of this project, is to better understand the fluctuation of the level of uric acid in traumatized patients by making serial measurements during their hospitalization in the intensive care unit. In addition, the determinants (e.g. type of trauma, diseases, interventions) of the blood level of uric acid and its association with the development of organ failure will be sought.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Multiple trauma patients admitted in the trauma center and requiring ICU admission.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Direct admission to trauma center\n* ≤ 3h after trauma\n* ISS ≥ 16\n* Received at least 1L of fluid at ER entrance\n\nExclusion Criteria:\n\n* Isolated head injury\n* Isolated spine injury\n* Chemotherapy within the last month\n* Hematologic disease\n* Chronic hemodialysis\n* Uricase treatment within the last week\n* Expected death within 48h'}, 'identificationModule': {'nctId': 'NCT03622632', 'briefTitle': 'Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association', 'organization': {'class': 'OTHER', 'fullName': "Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal"}, 'officialTitle': 'Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association', 'orgStudyIdInfo': {'id': '263425'}}, 'contactsLocationsModule': {'locations': [{'zip': 'H4J1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital du Sacré-Cœur de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal", 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonds de la Recherche en Santé du Québec', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Emmanuel Charbonney', 'investigatorAffiliation': "Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal"}}}}