Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT05842616
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2023-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol In Sepsis Induced Encephalopathy:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D001927', 'term': 'Brain Diseases'}], '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': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-03', 'studyFirstSubmitDate': '2023-04-15', 'studyFirstSubmitQcDate': '2023-05-03', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensive care unit (ICU) mortality', 'timeFrame': '28 day or till death which earlier', 'description': 'Incidence of Intensive care unit (ICU) stay will be recorded'}], 'secondaryOutcomes': [{'measure': 'Mean arterial pressure', 'timeFrame': '24 hours', 'description': 'Fluid resuscitation will be started using crystalloids at a rate of 4 to 6 ml/kg with reevaluation after 15 minutes.\n\nIf MAP is still less than 65 mmhg, fluid resuscitation should be continued at a rate of 4 to 6 ml/kg with reevaluation after another 15 minutes up to 30 ml/kg.\n\nVasopressors will be started if the patient is still hypotensive during or after resuscitation without delay even peripherally to avoid delay until central venous access is secured (norepinephrine is the first line agent preferred over other vasopressors).'}, {'measure': 'Norepinephrine titration', 'timeFrame': '24 hours', 'description': 'Fluid resuscitation will be started using crystalloids at a rate of 4 to 6 ml/kg with reevaluation after 15 minutes.\n\nIf MAP is still less than 65 mmhg, fluid resuscitation should be continued at a rate of 4 to 6 ml/kg with reevaluation after another 15 minutes up to 30 ml/kg.\n\nVasopressors will be started if the patient is still hypotensive during or after resuscitation without delay even peripherally to avoid delay until central venous access is secured (norepinephrine is the first line agent preferred over other vasopressors).'}, {'measure': 'Cerebral perfusion pressure', 'timeFrame': '24 hours', 'description': 'Cerebral perfusion pressure (CPP) will be done using transcranial doppler.'}, {'measure': 'Outcome of encephalopathy', 'timeFrame': '28 day', 'description': 'Encephalopathy outcome at ICU discharge using Glasgow coma scale (GCS)'}, {'measure': 'SOFA score', 'timeFrame': 'Up to 4 weeks.', 'description': 'SOFA score at ICU admission and discharge.'}, {'measure': 'Length of ICU stay', 'timeFrame': 'At least 28 days', 'description': 'Length of ICU stay'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Norepinephrine', 'Encephalopathy']}, 'referencesModule': {'references': [{'pmid': '39755598', 'type': 'DERIVED', 'citation': 'Salem MS, Abosabaa MA, Abd El Ghafar MS, Ei-Gendy HMEM, Alsherif SEI. Norepinephrine titration in patients with sepsis-induced encephalopathy: cerebral pulsatility index compared to mean arterial pressure guided protocol: randomized controlled trial. BMC Anesthesiol. 2025 Jan 4;25(1):5. doi: 10.1186/s12871-024-02814-0.'}]}, 'descriptionModule': {'briefSummary': 'The aim of our study is to compare between transcranial doppler pulsatility index and mean arterial blood pressure in guiding management of sepsis induced encephalopathy.', 'detailedDescription': 'Sepsis induced encephalopathy is the most frequent sepsis related organ dysfunction. It appears early during the course of infection, often before any other organ involvement in up to 70% of hospitalized septic patients and is associated with significant change of cerebral circulation caused by redistribution of blood flow during sepsis that accompanies the abnormal inflammatory response during an infection, in absence of direct central nervous system involvement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Must had clinical diagnosis of sepsis induced encephalopathy.\n\nExclusion Criteria:\n\n* Refusal to participate in the study.\n* Cerebral infection.\n* Known cerebral lesions (Neoplasm, Traumatic brain injury, Stroke, Ischemic or hemorrhagic cerebrovascular lesions, high intracranial pressure).\n* Known severe carotid stenosis (\\>70％).\n* Intoxication due to drugs.\n* Pregnancy.\n* Patients supported by intra-aortic balloon pumb (IABP).'}, 'identificationModule': {'nctId': 'NCT05842616', 'briefTitle': 'Cerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol In Sepsis Induced Encephalopathy:', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Norepinephrine Titration In Patients With Sepsis Induced Encephalopathy: Cerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol', 'orgStudyIdInfo': {'id': '35559/6/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial doppler pulsatility index guided protocol', 'description': 'Norepinephrine titration that will be guided by Transcranial doppler (TCD) pulsatility index.', 'interventionNames': ['Other: Transcranial doppler pulsatility index guided protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mean arterial blood pressure guided protocol', 'description': 'Norepinephrine titration that will be guided by Mean arterial blood pressure (MAP).', 'interventionNames': ['Other: Mean arterial blood pressure guided protocol']}], 'interventions': [{'name': 'Transcranial doppler pulsatility index guided protocol', 'type': 'OTHER', 'description': 'Norepinephrine titration that will be guided by Transcranial doppler pulsatility index.', 'armGroupLabels': ['Transcranial doppler pulsatility index guided protocol']}, {'name': 'Mean arterial blood pressure guided protocol', 'type': 'OTHER', 'description': 'Norepinephrine titration that will be guided by Mean arterial blood pressure (MAP).', 'armGroupLabels': ['Mean arterial blood pressure guided protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'Elgharbia', 'country': 'Egypt', 'facility': 'Tanta University Hospitals', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Mai S Aboshaara, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant lecturer'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Mai Salah Salem', 'investigatorAffiliation': 'Tanta University'}}}}