Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT06759259
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2024-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mannitol Administration for Delerium Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'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': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2024-12-28', 'studyFirstSubmitQcDate': '2024-12-28', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Dynamics of brain damage markers', 'timeFrame': '1, 3, 7 days', 'description': 'Dynamics of brain damage markers (NSE, S100β)'}, {'measure': 'Dynamics of markers of systemic inflammation', 'timeFrame': '1, 3, 7 days', 'description': 'Dynamics of markers of systemic inflammation (IL-1, IL-6, IL-8, procalcitonin, presepsin)'}, {'measure': 'Early adverse LV remodeling', 'timeFrame': '1, 3, 7 days', 'description': 'Increase in ESV by 15% from the baseline'}], 'primaryOutcomes': [{'measure': 'delirium', 'timeFrame': '1-14 days', 'description': 'Development of delirium during hospitalization'}], 'secondaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': '1-30 days', 'description': 'Death during hospitalization from all causes'}, {'measure': 'In-hospital LOS', 'timeFrame': '1-30 lays', 'description': 'Lenght of stay in hospital'}, {'measure': 'ICU-LOS', 'timeFrame': '1-30 days', 'description': 'Lenght of stay in ICU'}, {'measure': 'Re-hospitalization due to MACE', 'timeFrame': '1-90 days', 'description': 'Re-hospitalization due to MACE'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myocardial infarction', 'delirium', 'prevention', 'inflammation'], 'conditions': ['Myocardial Infarction (MI)', 'Delirium, Intensive Care Unit, Randomised Controlled Trial']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the efficacy of adjuvant administration of mannitol for the prevention of delirium in patients with myocardial infarction.', 'detailedDescription': 'The pathogenesis of delirium in patients with myocardial infarction has not been fully studied, as a result of which delirium is currently considered a polyetiological syndrome. The ideas about the pathogenesis of delirium are formulated in a number of concepts, among which the neuroinflammatory theory is the most promising for study. The development of a systemic inflammatory reaction of both infectious and aseptic nature can lead to a violation of the permeability of the blood-brain barrier, followed by subclinical cerebral edema and impaired neurotransmitter metabolism. A single study of the adjuvant use of mannitol for the prevention of delirium, conducted in 2020 (Hamiko M.) proved the effectiveness of mannitol in the prevention of delirium in patients who underwent surgical aortic valve replacement, and served as a theoretical and experimental prerequisite for this study.\n\nThe study is prospective, randomized, open-label, controlled. It is planned to include 40 patients with myocardial infarction aged 65 years or older on the first day of the disease ("pain-door" \\< 24 hours) and signs of a systemic inflammatory response (CRP\\> 25 mg / L) in the main and control groups in a 1: 1 ratio. All patients will receive standard treatment for myocardial infarction upon admission in accordance with current recommendations. Patients will be randomized using a random number generator, after which patients in the main group will receive adjuvant therapy with mannitol at a dose of 1000 mg / kg according to the following scheme: bolus 250 mg / kg + infusion 66.6 mg / kg / hour until a total dose of 1000 mg / kg is reached. Patients in the control group will receive standard treatment for myocardial infarction. It is planned to evaluate clinical, laboratory, functional data and take blood samples for the study of markers of systemic inflammation and brain damage and other biomarkers on days 1, 3 and 7. Evaluation of remote outcomes is planned on days 30 and 90.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the first day of development of myocardial infarction with signs of systemic inflammation and initial normal mental status and the absence of previously known pathological processes of the brain and psychiatric disorders.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65 and over\n* Myocardial infarction in the first day of illness ("pain to door" time \\< 254 hours)\n* Serum CRP \\> 25 mg/L\n\nExclusion Criteria:\n\n* A known pathological process in the brain, psychiatric disorders\n* Impossibility of conducting an assessment CAM-ICU'}, 'identificationModule': {'nctId': 'NCT06759259', 'acronym': 'MAD', 'briefTitle': 'Mannitol Administration for Delerium Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Tomsk National Research Medical Center of the Russian Academy of Sciences'}, 'officialTitle': 'Mannitol Adjuvant Administration for Delerium Prevention', 'orgStudyIdInfo': {'id': '231'}}, 'contactsLocationsModule': {'locations': [{'zip': '634012', 'city': 'Tomsk', 'state': 'Tomsk Oblast', 'country': 'Russia', 'facility': 'Cardiology Reserch Institute Tomsk National Research Centre', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}], 'overallOfficials': [{'name': 'Oleg Panteleev, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tomsk NRMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tomsk National Research Medical Center of the Russian Academy of Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}