Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT06984302
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2025-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A PREDICTIVE ALGORITHM IN AORTIC SURGERY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2025-05-14', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time weighted average of mean arterial presure under 65 mmHg', 'timeFrame': 'at the end of surgery', 'description': 'we will assess the magnitude of intraoperative arterial hypotension'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemodynamic']}, 'descriptionModule': {'briefSummary': 'We will enroll patients scheduled for abdominal aortic aneurysm repair and divide in two groups; in the control group the hemodynamic optimization will be made based on standard cardiovascular parameters showed in the Hemosphere platform. In the interventional group the hemodynamic optimization will be made based on the hypotension prediction index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* planned aortic surgery acceptance of written informed consent\n\nExclusion Criteria:\n\n* body mass index \\> 35 kg/m2\n* atrial fibrillation\n* urgent surgery\n* end-stage renal disease\n* pregnancy\n* refusal of the consent'}, 'identificationModule': {'nctId': 'NCT06984302', 'acronym': 'HYVAS', 'briefTitle': 'A PREDICTIVE ALGORITHM IN AORTIC SURGERY', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'HYPOTENSION PREDICTION INDEX FOR HEMODYNAMIC OPTIMIZATION IN MAJOR VASCULAR SURGERY', 'orgStudyIdInfo': {'id': '7458'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'proactive group', 'description': 'in this group patients will be managed by a predictive hemodynamic algorithm', 'interventionNames': ['Other: proactive therapy']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'drugs and fluids will be given based on mean arterial pressure and stroke volume variation respectively'}], 'interventions': [{'name': 'proactive therapy', 'type': 'OTHER', 'description': 'drugs and fluids will be given based on the hypotension prediction index', 'armGroupLabels': ['proactive group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00148', 'city': 'Rome', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Russo', 'role': 'CONTACT', 'email': 'andrea.russo@policlinicogemelli.it', 'phone': '+39-06-30153160'}], 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Andrea Russo, medical doctor', 'role': 'CONTACT', 'email': 'andrea.russo@policlinicogemelli.it', 'phone': '+39-0630153160'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'RUSSO ANDREA', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}