Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT00491192
Status:
UNKNOWN
Last Update Posted:
2007-09-20
First Post:
2007-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normothermia in Patients With Acute Cerebral Damage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D005334', 'term': 'Fever'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'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': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2009-06'}, 'lastUpdateSubmitDate': '2007-09-19', 'studyFirstSubmitDate': '2007-06-25', 'studyFirstSubmitQcDate': '2007-06-25', 'lastUpdatePostDateStruct': {'date': '2007-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maintenance of normothermia', 'timeFrame': 'within 14 days from ICU admission'}], 'secondaryOutcomes': [{'measure': 'Behaviour of intracranial pressure and cerebral perfusion pressure. Influence on six month outcome.', 'timeFrame': 'Within 14 days from ICU admission/Six months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fever', 'Acute cerebral damage', 'Normothermia', 'Diclofenac', 'ICU', 'Outcome', 'Intracranial pressure', 'Cerebral perfusion pressure', 'Traumatic brain injury', 'Subarachnoid hemorrhage'], 'conditions': ['Traumatic Brain Injury', 'Subarachnoid Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The purpose of our study is to verify wherever normothermia (achieved with diclofenac administration) may improve intracranial pressure control and may limit secondary cerebral damage thus positively influencing outcome in patients with acute cerebral damage admitted to ICU.', 'detailedDescription': 'Pyrexia can exacerbate ischemic neuronal damage and physiological dysfunction after traumatic brain injury and subarachnoid hemorrhage.Fever also represent an important issue occurring in 78% of patients with acute cerebral damage admitted to intensive care unit (ICU). For those patients, normothermia is actually recommended in order to reduce secondary cerebral damage and to control intracranial pressure, that are known to worsen long term prognosis. Our primary endpoint is to maintain normothermia in patients with acute cerebral damage (axillary temperature \\< 38°C or internal temperature \\< 38,8°C) administering diclofenac. We will also investigate the corresponding behaviour of intracranial pressure and cerebral perfusion pressure.\n\nComparison(s): We will compare two different doses of subcutaneous diclofenac (0,35 mg/kg - 1/3 a vial - vs 0,5 mg/Kg - 1/2 vial) to continuous intravenous of 0,48 mg/kg diclofenac for 12 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with severe traumatic injury or subarachnoid hemorrhage in coma (GCS\\<8), intubated, mechanically ventilated with intracranial pressure (ICP) and invasive arterial pressure monitoring\n\nExclusion Criteria:\n\n* Know adverse reactions with NSAI\n* Platelets count \\< 20,000/dl\n* Gastric or duodenal ulceration in active phase\n* Hepatic insufficiency, cirrhosis or previous liver transplant\n* Acute or chronic renal insufficiency\n* Coronary insufficiency, acute myocardial infarct in the previous 6 month\n* Barbiturate coma\n* Patients in therapy with acetylsalicylic acid, lithium, digoxin, methotrexate and cyclosporin.\n* Known or suspected pregnancy'}, 'identificationModule': {'nctId': 'NCT00491192', 'briefTitle': 'Normothermia in Patients With Acute Cerebral Damage', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'Normothermia in Patients With Acute Cerebral Damage', 'orgStudyIdInfo': {'id': '1575'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Diclofenac', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Laura Ghisoni, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katia Canavesi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Nino Stocchetti, MD', 'role': 'CONTACT', 'email': 'stocchet@policlinico.mi.it', 'phone': '0039.02.5503.5517'}], 'overallOfficials': [{'name': 'Nino Stocchetti, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ospedale Maggiore Policlinico Mangiagalli e Regina Elena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}}}}