Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT04398069
Status:
UNKNOWN
Last Update Posted:
2020-05-21
First Post:
2020-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D065166', 'term': 'Sepsis-Associated Encephalopathy'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'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': 'D001927', 'term': 'Brain Diseases'}, {'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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-18', 'studyFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2020-05-18', 'lastUpdatePostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality at day 28', 'timeFrame': '28 days after ICU admission', 'description': 'Mortality at day 28'}], 'secondaryOutcomes': [{'measure': 'Incidence of sepsis associated encephalopathy', 'timeFrame': '28 days after ICU admission', 'description': 'sepsis associated encephalopathy assessed by CAM-ICU and GCS scores'}, {'measure': 'Incidence of sepsis related organ failures', 'timeFrame': '28 days after ICU admission', 'description': 'sepsis related organ failures assessed with SOFA score'}, {'measure': 'Length of ICU stay', 'timeFrame': '30 days after end of randomization', 'description': 'Length of ICU stay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trans cranial doppler ultrasonography, hemodynamics, septic shock, sepsis associated encephalopathy'], 'conditions': ['Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock']}, 'descriptionModule': {'briefSummary': 'Randomized, controlled, prospective trial, including ICU patients with Sepsis or septic Shock, at the early phase.\n\npatients will be randomized in 2 groups regarding the hemodynamic management and catecholamin doses:\n\n* Group 1: standard hemodynamic goals and catecholamin infusion to achieve: mean arterial pressure \\> or equal to 65 mmHg and diastolic arterial pressure \\> ou equal to 50 mmHg within the first 60 minutes.\n* Group 2: personalized hemodynamic goals and catecholamin infusion until normal transcranial doppler: IP\\<1,2.', 'detailedDescription': 'Randomized, controlled, prospective trial, including ICU patients with Sepsis or septic Shock, at the early phase.\n\npatients will be randomized in 2 groups regarding the hemodynamic management and catecholamin doses:\n\n* Group 1: standard hemodynamic goals and cathecolamin infusion to achieve: mean arterial pressure \\> or equal to 65 mmHg and diastolic arterial pressure \\> ou equal to 50 mmHg within the first 60 minutes.\n* Group 2: personalized hemodynamic goals and cathecolamin infusion until normal transcranial doppler: IP\\<1,2.\n\nFor the 2 groups, standard management including: microbiological sampling, early broad spectrum anti infective therapy, fluid management and decreasing of blood lactate levels, will be aimed within the first 60 minutes.\n\nFor the Group 2 patients: personalized hemodynamic management will be maintained during 72 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All ICU patients presenting septic shock\n* No criteria of traumatic or vascular brain injury\n\nExclusion Criteria:\n\n* Patients with refractory septick shock\n* rapid fatal evolution: before 72 hours\n* No individualisation of the MCA ultrasonographic window'}, 'identificationModule': {'nctId': 'NCT04398069', 'briefTitle': 'Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Mongi Slim Hospital'}, 'officialTitle': 'Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock', 'orgStudyIdInfo': {'id': 'Hemodynamic optimization ICU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Group', 'description': 'standard hemodynamic goals and catecholamin infusion to achieve: mean arterial pressure \\> or equal to 65 mmHg and diastolic arterial pressure \\> ou equal to 50 mmHg within the first 60 minutes.'}, {'type': 'EXPERIMENTAL', 'label': 'personalized hemodynamic goals Group', 'description': 'Personalized hemodynamic goals and catecholamin infusion to achieve normal cerebral perfusion assessed by transcranial doppler: PI \\< 1,2.', 'interventionNames': ['Procedure: hemodynamic optimisation aiming to achieve normal cerebral perfusion']}], 'interventions': [{'name': 'hemodynamic optimisation aiming to achieve normal cerebral perfusion', 'type': 'PROCEDURE', 'description': 'hemodynamic optimisation aiming to achieve normal cerebral perfusion: titration of catecholamin infusion.', 'armGroupLabels': ['personalized hemodynamic goals Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2046', 'city': 'Tunis', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Mhamed Sami Mebazaa, professor', 'role': 'CONTACT', 'email': 'msmebazaa@gmail.com', 'phone': '0021622252589'}, {'name': 'Asma Ben Souissi, Ass Prof', 'role': 'CONTACT', 'email': 'bsouissiasma@gmail.com', 'phone': '0021698336883'}], 'facility': 'Mongi Slim Hospital', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'centralContacts': [{'name': 'Mhamed Sami Mebazaa, professor', 'role': 'CONTACT', 'email': 'msmebazaa@gmail.com', 'phone': '0021622252589'}, {'name': 'Asma Ben Souissi, Ass Prof', 'role': 'CONTACT', 'email': 'bsouissiasma@gmail.com', 'phone': '0021698336883'}], 'overallOfficials': [{'name': 'Mhamed Sami Mebazaa, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mongi Slim Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mongi Slim Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor head of the anesthesia and intensive care department', 'investigatorFullName': 'Mhamed Sami Mebazaa', 'investigatorAffiliation': 'Mongi Slim Hospital'}}}}