Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-03-15 @ 4:39 AM
Study NCT ID:
NCT00505505
Status:
UNKNOWN
Last Update Posted:
2008-08-07
First Post:
2007-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Insulin Therapy for Strict Glycemic Control in Neurosurgical Patients: Safety and Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'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'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000006', 'term': 'insulin, neutral'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'lastUpdateSubmitDate': '2008-08-06', 'studyFirstSubmitDate': '2007-07-20', 'studyFirstSubmitQcDate': '2007-07-20', 'lastUpdatePostDateStruct': {'date': '2008-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Episodes of hypoglycemia'}], 'secondaryOutcomes': [{'measure': 'Infection rate', 'timeFrame': 'during the study'}, {'measure': 'Vasospasm rate', 'timeFrame': 'during the study'}, {'measure': 'Mortality', 'timeFrame': '6 months follow up'}, {'measure': 'Neurologic status', 'timeFrame': '6 months follow up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neurointensive care', 'Intensive insulin infusion', 'Hypoglycemia', 'Postoperative Mortality', 'Postoperative Morbidity', 'Neurologic outcome'], 'conditions': ['Subarachnoid Hemorrhage', 'Traumatic Brain Injury', 'Intracranial Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Strict glycemic control improves mortality and morbidity of patients admitted to the postoperative intensive care unit (ICU). The investigators would like to know if this therapy could improve the long term neurologic and cognitive outcomes of patients treated for acute subarachnoid hemorrhage with either a surgical or intravascular approach.', 'detailedDescription': 'Intensive Insulin Therapy and Strict Glycemic Control (80-120 mg/dL) Versus Standard Insulin Therapy in Neurosurgical Intensive Care Patients (Subarachnoid Hemorrhage, Traumatic Brain Injury, Intracranial Expanding Lesion): Safety, and Efficacy (Mortality, Morbidity, Long Term Neurologic Outcome).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subarachnoid hemorrhage\n* Traumatic brain injury\n* Intracranial hemorrhage'}, 'identificationModule': {'nctId': 'NCT00505505', 'briefTitle': 'Intensive Insulin Therapy for Strict Glycemic Control in Neurosurgical Patients: Safety and Efficacy', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Effects of Intensive Insulin Therapy on Mortality, Morbidity and Long Term Neurologic Outcome in Neurosurgical Intensive Care Patients', 'orgStudyIdInfo': {'id': '1781964'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Insulin infusion rate titrated to maintain glycemia between 80 and 100 mg/dl', 'interventionNames': ['Drug: Insulin (Actrapid)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Insulin infusion rate titrated to maintain glycemia between 80 and 220 mg/dl', 'interventionNames': ['Drug: Insulin (Actrapid)']}], 'interventions': [{'name': 'Insulin (Actrapid)', 'type': 'DRUG', 'description': '50 UI Actrapid diluted in 50 ml of saline', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federico Bilotta, MD, PhD', 'role': 'CONTACT', 'email': 'bilotta@tiscali.it'}], 'facility': 'University of Rome La Sapienza', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Federico Bilotta, MD, PhD', 'role': 'CONTACT', 'email': 'bilotta@tiscali.it', 'phone': '39 339 33 708 22'}, {'name': 'Vincenzo Cuzzone', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Federico Bilotta, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anesthesiology, Critical Care and Pain Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}}}}