Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-03-27 @ 1:16 PM
Study NCT ID:
NCT03244293
Status:
UNKNOWN
Last Update Posted:
2023-11-22
First Post:
2017-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bispectral Index (BIS) for Classification of Procalcitonin (PCT) Sepsis Grades in Critically Ill Patients With Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2017-08-02', 'studyFirstSubmitQcDate': '2017-08-08', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bispectral Index (BIS)-Electroencephalography (EEG) derived parameter correlated to the severity of Sepsis as indicated by Procalcitonin (PCT) biomarker.', 'timeFrame': 'Time point 1= On CCU admission, Time point 2= day 3 of CCU admission, Time point 3= on release from CCU.', 'description': 'Bispectral Index (BIS)-Electroencephalography (EEG) derived parameter (scale from 0=brain dead to 100= normal EEG) will be monitored and correlated to the severity of Sepsis as indicated by daily measured Procalcitonin (PCT) biomarker (\\<0.5 micg/L =no sepsis up to 100 micg/L =Septic shock)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis, Severe']}, 'descriptionModule': {'briefSummary': 'To evaluate the discriminative power of BIS monitoring to classify the degree of mental state associated with the PCT graded sepsis cascade, and to assess its utility for monitoring the improvement or deterioration of sepsis.', 'detailedDescription': "To evaluate the discriminative power of BIS monitoring to classify the degree of mental state associated with the PCT graded sepsis cascade, and to assess its utility for monitoring the improvement or deterioration of sepsis. The primary endpoint of our study was to use an artefact-free 10-min mean BIS value to classify the degree of sepsis. As secondary endpoints, we correlated the mean BIS value to various mental state and sepsis parameters; PCT, C-reactive protein (CRP), Glasgow coma scale, and sequential organ failure assessment (SOFA) score. In a longitudinal study, patients' PCT sepsis grades were reassessed at a later time point and a second artefact-free 10-min mean BIS value was recorded to evaluate BIS evolution within the same patient."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critical Care patients with all grades of Sepsis monitored with bispectral index', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: patients with sepsis\n\n* patients with sepsis\n\nExclusion Criteria:\n\n* Patients who received drugs that would interfere with BIS monitoring'}, 'identificationModule': {'nctId': 'NCT03244293', 'acronym': 'BIS6', 'briefTitle': 'Bispectral Index (BIS) for Classification of Procalcitonin (PCT) Sepsis Grades in Critically Ill Patients With Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Suez Canal University'}, 'officialTitle': 'Sensitivity and Specificity of Bispectral Index (BIS) for Classification of Procalcitonin (PCT) Sepsis Grades in Critically Ill Patients With Sepsis, Severe Sepsis and Septic Shock and Multiple Organ Failure (MOF)', 'orgStudyIdInfo': {'id': 'MUGraz6'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dalian', 'state': 'Dalian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhaoyang Xiao, MD', 'role': 'CONTACT'}, {'name': 'Ashraf Dahaba, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}], 'centralContacts': [{'name': 'Ashraf Dahaba', 'role': 'CONTACT', 'email': 'ashraf.dahaba@medunigraz.at', 'phone': '00436509006761'}], 'overallOfficials': [{'name': 'Ashraf Dahaba, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Suez Canal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suez Canal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Ashraf A. Dahaba', 'investigatorAffiliation': 'Suez Canal University'}}}}