Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 5:42 PM
Study NCT ID:
NCT05448534
Status:
COMPLETED
Last Update Posted:
2023-02-28
First Post:
2022-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electroencephalographic Patterns of Septic Patients and Its Correlation With Cognitive Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2022-07-02', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electroencephalographic patterns', 'timeFrame': '3 months after hospital discharge', 'description': "Electroencephalographic patterns determined by Sinek and Young scales. The Synek outcome Scale ranges from normal (alpha dominant rhythm) to suppression (worst outcome). The scale assesses the outcome of patients with sepsis.\n\nYoung's Scale Electroencephalographic classification of coma assesses outcome of patients with sepsis Outcome varies from normal (Delta/Theta Rhythm \\> 50% of record). worst result Suppression The two scales are complementary."}, {'measure': 'Cognitive evaluation', 'timeFrame': '3 months after hospital discharge', 'description': 'Cognitive dysfunction measured by Montreal Cognitive Assessment (MoCA)'}], 'secondaryOutcomes': [{'measure': 'electroencephalographic patterns and 28 days mortality .', 'timeFrame': '28 days', 'description': "Electroencephalographic patterns determined by Sinel and Young scales and 28 days .mortality. The Synek outcome Scale ranges from normal (alpha dominant rhythm) to suppression (worst outcome). The scale assesses the outcome of patients with sepsis.\n\nYoung's Scale Electroencephalographic classification of coma assesses outcome of patients with sepsis Outcome varies from normal (Delta/Theta Rhythm \\> 50% of record). worst result Suppression The two scales are complementary."}, {'measure': 'Quality of Life (SF-36) after 3 months of discharge', 'timeFrame': '3 months after hospital discharge', 'description': 'Quality of life determined through Short-Form Health Survey (SF-36). Scores range from 0 to 100, 0 indicating the less favorable health status and 100 the most favorable one.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eletroencephalography', 'Sepsis', 'Septic shock', 'Critical care', 'cognitive dysfunction', 'Montreal cognitive assessment'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '26447697', 'type': 'RESULT', 'citation': "Azabou E, Magalhaes E, Braconnier A, Yahiaoui L, Moneger G, Heming N, Annane D, Mantz J, Chretien F, Durand MC, Lofaso F, Porcher R, Sharshar T; Groupe d'Explorations Neurologiques en Reanimation (GENER). Early Standard Electroencephalogram Abnormalities Predict Mortality in Septic Intensive Care Unit Patients. PLoS One. 2015 Oct 8;10(10):e0139969. doi: 10.1371/journal.pone.0139969. eCollection 2015."}, {'pmid': '8627969', 'type': 'RESULT', 'citation': 'Eidelman LA, Putterman D, Putterman C, Sprung CL. The spectrum of septic encephalopathy. Definitions, etiologies, and mortalities. JAMA. 1996 Feb 14;275(6):470-3.'}, {'pmid': '20978258', 'type': 'RESULT', 'citation': 'Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553.'}, {'pmid': '19384197', 'type': 'RESULT', 'citation': 'Oddo M, Carrera E, Claassen J, Mayer SA, Hirsch LJ. Continuous electroencephalography in the medical intensive care unit. Crit Care Med. 2009 Jun;37(6):2051-6. doi: 10.1097/CCM.0b013e3181a00604.'}, {'pmid': '1552002', 'type': 'RESULT', 'citation': 'Young GB, Bolton CF, Archibald YM, Austin TW, Wells GA. The electroencephalogram in sepsis-associated encephalopathy. J Clin Neurophysiol. 1992 Jan;9(1):145-52. doi: 10.1097/00004691-199201000-00016.'}, {'pmid': '25482125', 'type': 'RESULT', 'citation': 'Hosokawa K, Gaspard N, Su F, Oddo M, Vincent JL, Taccone FS. Clinical neurophysiological assessment of sepsis-associated brain dysfunction: a systematic review. Crit Care. 2014 Dec 8;18(6):674. doi: 10.1186/s13054-014-0674-y.'}]}, 'descriptionModule': {'briefSummary': 'The investigators evaluated the electroencephalographic pattern by the Sinek and Young scales during ICU stay and its correlation with cognitive impairment determined by the Montreal Cognitive Assessment (MOCA) in septic patients after 3 months of ICU discharge..', 'detailedDescription': 'The investigators prospectively evaluate patients with sepsis and septic shock expected to stay in the intensive care unit (ICU) for at least 4 days. We used Sinek and Young scales to classify electroencephalographic patterns during ICU stay (in the first 24 hours after admission and in the third ICU day) and correlate with cognitive outcome evaluated with MOCA score 3 months after ICU discharge. The investigators evaluate as primary outcome the association between electroencephalographic abnormalities and cognitive dysfunction measured by the Montreal Cognitive Assessment (MoCA) 3 months after ICU discharge and secondary outcomes as association between electroencephalographic patterns and 28 days mortality, Quality of Life (SF-36) after 3 months of discharge, ventilator free days, vasoactive drug free days and Glasgow outcome scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All critically ill patients with sepsis and septic shock expected to stay in the intensive care unit (ICU) for at least 4 days admitted to 3 medical ICUs and 2 surgical ICUs of a tertiary hospital in Brazil.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIncluded were patients aged above 18 years, who were expected to stay in the ICU for at least 4 days, between November 2021 and November 2022.\n\n\\-\n\nExclusion Criteria:\n\n* CNS infections,\n* Structural abnormalities of the CNS, known\n* Liver or uremic encephalopathy,\n* Advanced dementia (Mini mental \\< 9),\n* Psychiatric disorder\n* Epilepsy.'}, 'identificationModule': {'nctId': 'NCT05448534', 'briefTitle': 'Electroencephalographic Patterns of Septic Patients and Its Correlation With Cognitive Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Sao Domingos'}, 'officialTitle': 'Electroencephalographic Patterns of Septic Patients and Its Correlation With Cognitive Outcomes', 'orgStudyIdInfo': {'id': '54'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Eletroencephalography', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Montreal Cognitive Assessment (MoCA)', 'Sinek and young scales'], 'description': 'We used Sinek and Young Scale to classify electroencephalographic patterns and cognitive outcome with MOCA score.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '65060-645', 'city': 'São Luís', 'state': 'Maranhão', 'country': 'Brazil', 'facility': 'Icu Hospital Sao Domingos', 'geoPoint': {'lat': -2.52972, 'lon': -44.30278}}], 'overallOfficials': [{'name': 'JOSE AZEVEDO, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Sao Domingos'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Sao Domingos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ICU Coordinator', 'investigatorFullName': 'José Raimundo Araujo de Azevedo', 'investigatorAffiliation': 'Hospital Sao Domingos'}}}}