Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT04996420
Status:
TERMINATED
Last Update Posted:
2023-06-01
First Post:
2020-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Goal Directed Fluid Therapy Versus Liberal Fluid Regimen in Primary Elective Hip Artrhoplasty
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': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'change in surgical technique (lateral approach vs anterior approach for hip arthroplasty, determining a change in patient intraoperative positioning)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-30', 'studyFirstSubmitDate': '2020-01-29', 'studyFirstSubmitQcDate': '2021-07-30', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total perioperative hypotension time defined by a mean arterial pressure < 65mmHg, from arrival in the anesthesia induction room to resolution of spinal block in Recovery Room (i.e. up to 8 hours)', 'timeFrame': 'from arrival in the anesthesia induction room to resolution of spinal block in Recovery Room'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthroplasty, Replacement, Hip', 'Anesthesia, Spinal', 'Hemodynamic Monitoring', 'Crystalloid Solutions']}, 'descriptionModule': {'briefSummary': "Patients undergoing elective primary total hip replacement and spinal anesthesia may encounter significant hemodynamic instability.\n\nThe study is a randomized controlled type and is aimed at comparing how perioperatory hypotension and fluid regimen are managed using Clearsight non invasive monitoring system or PAM monitoring.\n\nThe primary endpoint is to evaluate total duration of hypotension, defined as a MAP \\< 65 mmHg, calculated during all the perioperatory time.\n\nFifty-eight patients, aged 50-80 years, with an American Society of Anaesthesiologists' (ASA) score I, II and III were enrolled and split in two groups (Clearsight and control group). Patients were monitored both with the EV1000 platform, the Clearsight finger-cuff and MAP monitoring. Depending on the group, the fluid regimen was a goal directed fluid therapy or a liberal fluid regimen."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50-80 years\n* ASA I, II or III\n* primary elective hip arthroplasty\n\nExclusion Criteria:\n\n* spinal anesthesia contraindications\n* periferical vasculopaty\n* other diseases which indicates better an invasive monitoring by radial artery cannulation\n* atrial fibrillation\n* denial or inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04996420', 'briefTitle': 'Goal Directed Fluid Therapy Versus Liberal Fluid Regimen in Primary Elective Hip Artrhoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Goal Directed Fluid Management vs Liberal Fluid Regimen Based on Mean Arterial Pressure in Patients Undergoing Spinal Anesthesia for Primary Elective Hip Arthroplasty: a Randomized, Prospective, Controlled Study."', 'orgStudyIdInfo': {'id': 'Emospin 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clearsight', 'description': 'hemodynamic monitoring and goal directed fluid therapy guided by clearsight', 'interventionNames': ['Device: Clearsight non invasive hemodynamic monitoring']}, {'type': 'OTHER', 'label': 'Control', 'description': 'hemodynamic monitoring blinded and silenced, no goal directed fluid therapy. Fluid therapy based on clinical evaluation and mean arterial pressure by non-invasive monitoring', 'interventionNames': ['Device: Clearsight non invasive hemodynamic monitoring']}], 'interventions': [{'name': 'Clearsight non invasive hemodynamic monitoring', 'type': 'DEVICE', 'description': 'Goal directed fluid therapy fuided by Clearsight monitoring', 'armGroupLabels': ['Clearsight', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bologna', 'country': 'Italy', 'facility': 'IORizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Stefano Bonarelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Ortopedico Rizzoli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}