Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT06164405
Status:
COMPLETED
Last Update Posted:
2025-04-08
First Post:
2023-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arterial dP/dt Dependency on Loading Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2023-12-01', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dp/dt fluids dependency', 'timeFrame': 'intraoperative', 'description': 'measurement of dp/dtmax after fluid challenge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['emodinamica'], 'conditions': ['Intraoperative Hemodyamic Monitoring']}, 'descriptionModule': {'briefSummary': 'In the present study the investigators aim to assess the changes of the arterial dP/dtmax induced by fluids and vasoactive drugs during abdominal surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'surgical patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients scheduled for abdominal surgery informed consent acceptance\n\n\\-\n\nExclusion Criteria:\n\n* BMI\\> 30 Kg /m2;\n* Atrial Fibrillation;\n* Congestive heart failure with FE \\<35% and/or NYHA≥3;\n* Severe known cardiac valve disease;\n* Emergency surgery\n* Shock or any acute conditions who required admission intensive care unit'}, 'identificationModule': {'nctId': 'NCT06164405', 'acronym': 'REABILITY', 'briefTitle': 'Arterial dP/dt Dependency on Loading Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'RESPONSE OF ARTERIAL dP/dt TO FLUIDS AND VASOACTIVE DRUGS DURING ABDOMINAL SURGERY: A PROSPECTIVE PILOT STUDY', 'orgStudyIdInfo': {'id': '6166'}}, 'armsInterventionsModule': {'interventions': [{'name': 'arterial dp/dtmax', 'type': 'DEVICE', 'description': 'to assess the variations of the arterial dp/dt max after drugs or fluids administration'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00148', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitairo Agostino Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor', 'investigatorFullName': 'RUSSO ANDREA', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}