Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-02-19 @ 8:31 AM
Study NCT ID:
NCT04100369
Status:
UNKNOWN
Last Update Posted:
2019-09-24
First Post:
2019-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Admission Blood Glucose as a Predictor of Morbidity and Mortality in Polytraumatized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}], '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': 100}, 'targetDuration': '3 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-20', 'studyFirstSubmitDate': '2019-09-20', 'studyFirstSubmitQcDate': '2019-09-20', 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Admission blood glucose as a predictor of morbidity and mortality in polytraumatized patients', 'timeFrame': 'baseline', 'description': 'to investigate the admission blood glucose level as a predictor of morbidity and mortality in poly traumatized patients'}], 'secondaryOutcomes': [{'measure': 'Admission blood glucose as a predictor of morbidity and mortality in polytraumatized patients', 'timeFrame': 'baseline', 'description': 'correlation of blood glucose level to serum lactate , interlukin6 , C reactive protein , coagulation profile and their use as biomarkers in polytraumatized patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['shock , poly trauma , serum lactate'], 'conditions': ['Blood Glucose, High']}, 'referencesModule': {'references': [{'pmid': '15179246', 'type': 'BACKGROUND', 'citation': 'Laird AM, Miller PR, Kilgo PD, Meredith JW, Chang MC. Relationship of early hyperglycemia to mortality in trauma patients. J Trauma. 2004 May;56(5):1058-62. doi: 10.1097/01.ta.0000123267.39011.9f.'}, {'pmid': '26815974', 'type': 'BACKGROUND', 'citation': 'Lichtveld RA, Panhuizen IF, Smit RB, Holtslag HR, van der Werken C. Predictors of Death in Trauma Patients who are Alive on Arrival at Hospital. Eur J Trauma Emerg Surg. 2007 Feb;33(1):46-51. doi: 10.1007/s00068-007-6097-6. Epub 2007 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'In polytrraumatized patients, Does hyperglycaemia on admission increase the risk of morbidity and mortality compared to polytraumatised patients with normal blood glucose level ?', 'detailedDescription': 'Trauma is still the leading cause of death in young adults and a major cause of morbidity and mortality at all ages.(1,2). Polytrauma is defined as injury to several physical regions or organ systems, where at least one injury or the combination of several injuries are life threatening with the severity of injury being equal or \\>16 on the scale of the Injury Severity Score (ISS). Prediction of mortality in trauma patients is an important part of trauma care (3). The trauma and injury severity score (TRISS) and Acute Physiology and Chronic Health Evaluation IV (APACHE IV) are used commonly to predict injury severity and risk of mortality. Although it is regarded as the international standard in trauma scoring, it has complex calculating and incorporates the Glasgow Coma Scale (GCS) for neurological evaluation (4). Regardless of the accuracy of trauma scores, is based on an anatomical description of every injury and cannot be assigned to the patients until a full diagnostic procedure has been performed(5) . Many studies have revealed alteration in glucose metabolism in trauma and proportional relation of its high level to the degree of injury (6). hyperglycaemia is associated with similar complications as uncontrolled diabetes, including an increased mortality, an increased number of infectious complications, and poor wound healing. The presence of elevated blood glucose also impedes normal host defences against infection and impairs the normal inflammatory response (7.8).\n\n* Therefore, this study will be conducted to compare between alterations in easy and rapid predictors as glucose level, base deficit and lactate and difficult and slow predictors as TRISS and APACHE IV. So, it could be considered an early and easy rapid predictor of outcome .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'using blood glucose as an easy and a rapid predictor of morbidity and mortality in poly traumatized patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age \\>= 18 years\n\n * Polytrauma ISS \\>= 18\n * Recent polytrauma patients who are directly transferred by the ambulance from the scene of accident to assiut university hospital and did not receive resuscitative measurements in another hospital\n\nExclusion Criteria:\n\n* known co-morbidities affecting blood glucose level like :\n\n * Pregnant women\n * Diabetic patients'}, 'identificationModule': {'nctId': 'NCT04100369', 'briefTitle': 'Admission Blood Glucose as a Predictor of Morbidity and Mortality in Polytraumatized Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Admission Blood Glucose as a Predictor of Morbidity and Mortality in Polytraumatized Patients', 'orgStudyIdInfo': {'id': 'blood glucose'}}, 'armsInterventionsModule': {'interventions': [{'name': 'laboratory', 'type': 'DIAGNOSTIC_TEST', 'description': 'Arm'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'tamer armanious, MD', 'role': 'CONTACT', 'email': 'tamerrefaat2244@gmail.com', 'phone': '+201203523938'}], 'overallOfficials': [{'name': 'Hossam Abubeih, ass.prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'fasil adam, prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'tamer refaat hanna armanious', 'investigatorAffiliation': 'Assiut University'}}}}