Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT04078503
Status:
UNKNOWN
Last Update Posted:
2019-09-06
First Post:
2019-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuroinflammation During ICU-associated Delirium in Critically Ill Patients and Its Association With Structural and Functional Brain Alterations: a Nested Case-control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D007249', 'term': 'Inflammation'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2021-06-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-01', 'studyFirstSubmitDate': '2019-03-30', 'studyFirstSubmitQcDate': '2019-09-01', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Neuroinflammation biomarkers in patients developing delirium.', 'timeFrame': '15 days', 'description': 'Comparison of neuroinflammation biomarkers in patients developing delirium vs patients who do not develop delirium.'}], 'secondaryOutcomes': [{'measure': 'fMRI alteration', 'timeFrame': '6 months', 'description': 'Evaluation of brain functional alterations during delirium development (evaluated through resting state fMRI).'}, {'measure': 'Correlation between biomarkers alterations and fMRI alterations', 'timeFrame': '15 days', 'description': 'Evaluation of the correlation between serum neuroinflammation biomarkers alteration during delirium development and the alterations noted in during resting state fMRI'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neuroinflammation', 'fMRI', 'Functional MRI', 'ICU related delirium'], 'conditions': ['Delirium', 'Critical Illness']}, 'descriptionModule': {'briefSummary': 'With the present study, the authors aim to improve the knowledge of the pathophysiology of ICU-related delirium. In particular, the authors would like to clarify the possible correlation between neuroinflammation, evaluated longitudinally by serum dosage of 20 different neuroinflammation biomarkers, and brain structural and functional alterations (using brain fMRI).', 'detailedDescription': 'Pathophysiology of delirium is poorly understood; neuroinflammation and brain network disruption are claimed as possible causes of delirium.\n\nThe authors want to clarify the role of the alterations of different cellular components of neuroinflammation (neurons, glial cells, and endothelium) in delirium development. Moreover, the authors want to understand whether the neuroinflammation process could cause permanent structural and functional brain damage.\n\nIn a nested cross-sectional longitudinal case-control observational study in ICU admitted patients.\n\nThe objectives of the studies are as follow: 1) Neuroinflammation biomarkers evaluation in non-neurological ICU patients who develop delirium during ICU-stay (case) compared to matched non-delirious ICU patients (control), and 2) their correlation with brain structural and functional alterations evaluated with a resting-state fMRI protocol and PET.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will enroll 30 critically ill patients in the study (case) matched to 30 controls (see sample size calculation).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18\n* All patients admitted that would be expected to stay in ICU for at least 3 days\n\nExclusion Criteria:\n\n* Acute neurological condition\n* Chronic neurological condition (i.e., seizures, stroke, muscular illness).\n* Hematological malignancy or immunological disease.\n* Blood transfusion in the last 2 weeks\n* Ongoing sedation\n* Any condition which contraindicates MRI execution (presence of non-compatible devices or hemodynamic or respiratory instability).'}, 'identificationModule': {'nctId': 'NCT04078503', 'acronym': 'Delirium-fMRI', 'briefTitle': 'Neuroinflammation During ICU-associated Delirium in Critically Ill Patients and Its Association With Structural and Functional Brain Alterations: a Nested Case-control Study', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia'}, 'officialTitle': 'Neuroinflammation During ICU-associated Delirium in Critically Ill Patients and Its Association With Structural and Functional Brain Alterations: a Nested Case-control Study', 'orgStudyIdInfo': {'id': 'NP3468'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case', 'description': 'All patients aspected to stay in ICU for at least 3 days who will develop delirium'}, {'label': 'Control', 'description': 'All patients aspected to stay in ICU for at least 3 days who will not develop delirium (1:1 matched with the controls with a propensity score method).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '25123', 'city': 'Brescia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Simone Piva', 'role': 'CONTACT', 'email': 'simone.piva@unibs.it', 'phone': '+393332564230', 'phoneExt': '+393332564230'}, {'name': 'Fabio Turla', 'role': 'CONTACT', 'email': 'fabioturla2@gmail.com', 'phone': '+393332564230'}], 'facility': 'Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Already available', 'ipdSharing': 'YES', 'description': 'The database is in RedCap. We could share all data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pisa', 'class': 'OTHER'}, {'name': 'University of Turin, Italy', 'class': 'OTHER'}, {'name': 'University of Milano Bicocca', 'class': 'OTHER'}, {'name': 'Università degli Studi di Brescia', 'class': 'OTHER'}, {'name': 'Mie University', 'class': 'OTHER'}, {'name': 'Erasme University Hospital', 'class': 'OTHER'}, {'name': 'Maastricht University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Piva Simone', 'investigatorAffiliation': 'Università degli Studi di Brescia'}}}}