Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-01-01 @ 4:30 AM
Study NCT ID:
NCT05083403
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2021-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HPI (Hypotension Prediction Index) Care Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2021-10-06', 'studyFirstSubmitQcDate': '2021-10-06', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment if the use of the AcumenTM HPI Feature Software reduces the mean duration of hypotension (defined as MAP < 65mmHg)', 'timeFrame': 'From post-bypass period to the first 8-hour ICU period', 'description': 'Assessment if the use of the AcumenTM HPI Feature Software reduces the mean duration of hypotension (defined as MAP \\< 65mmHg)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['cardiopulmonary bypass'], 'conditions': ['Cardiopulmonary Bypass Surgery']}, 'descriptionModule': {'briefSummary': 'A prospective single-center randomized controlled trial to determine if guided hemodynamic management with the Acumen HPI technology in the OR and ICU can reduce the mean duration of hypotension in cardiac surgery patients requiring cardiopulmonary bypass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects who are at least 18 years of age\n2. Subjects who have signed the Informed Consent Form\n3. Subjects with planned pressure monitoring with an arterial line\n4. Subjects with planned sternotomy\n5. Subjects with planned general anesthesia\n6. Subjects who have ASA Physical Status ≤ 4\n7. Subjects with planned cerebral oximetry monitoring\n8. Subjects with planned overnight hospitalization\n9. Subjects with planned cardiopulmonary bypass (CPB) "on-pump" surgery\n\nExclusion Criteria:\n\n1. Subjects with a physical site area too limited for proper Sensor placement\n2. Subjects with contraindications for Arterial Line Placement;\n3. Subjects participating in another (interventional) study\n4. Subjects in whom an intraoperative MAP target will be \\< 65 mmHg\n5. Subjects with pre-op or pre-pump or post-pump LVEF \\< 15%\n6. Subjects requiring heart transplant\n7. Subjects with pre-existing circulatory support devices or planned circulatory support devices post-bypass\n8. Subjects requiring emergency surgery\n9. Subjects with known or identified severe PAH (defined as pulmonary systolic pressure\\> 70mmHg or mean pressures \\> 55mmHg) as determined by a pre-operative echo or intraoperative Swan-Ganz\n10. Subjects with cardiovascular instability in the operating room necessitating the need to go back on bypass for a subsequent run'}, 'identificationModule': {'nctId': 'NCT05083403', 'briefTitle': 'HPI (Hypotension Prediction Index) Care Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'A Randomized Trial of the Hypotension Prediction Index in the Cardiac Operating Room and the Intensive Care Unit', 'orgStudyIdInfo': {'id': '2020-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HPI Arm', 'description': 'AcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB', 'interventionNames': ['Device: AcumenTM HPI Software Feature']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-HPI Arm', 'description': 'Non-protocolized standard of care management per clinician and provider judgement.', 'interventionNames': ['Other: Non-protocolized Standard of Care']}], 'interventions': [{'name': 'AcumenTM HPI Software Feature', 'type': 'DEVICE', 'description': "The AcumenTM HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The AcumenTM HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor.", 'armGroupLabels': ['HPI Arm']}, {'name': 'Non-protocolized Standard of Care', 'type': 'OTHER', 'description': 'Non-protocolized standard of care to treat subjects', 'armGroupLabels': ['Non-HPI Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157-1009', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}