Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-02-01 @ 9:40 PM
Study NCT ID:
NCT05615168
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2022-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Hypotension Prediction Index to Reduce Intraoperative Hypotension in Major Thoracic Surgery
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': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-11', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-11-11', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time weighted average of area under hypotensive threshold', 'timeFrame': 'During surgery'}], 'secondaryOutcomes': [{'measure': 'Cumulative duration of hypotension', 'timeFrame': 'During surgery'}, {'measure': 'Number of hypotensive events', 'timeFrame': 'During surgery'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hypotension During Surgery']}, 'descriptionModule': {'briefSummary': 'Intraoperative hypotension is linked to increased incidence of perioperative adverse events such as myocardial and cerebrovascular infarction and acute kidney injury. Hypotension prediction index (HPI) is a novel machine learning guided algorithm which can predict hypotensive events using high fidelity analysis of pulse-wave contour. Goal of this trial is to determine whether use of HPI can reduce the number and duration of hypotensive events in patients undergoing major thoracic procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients over 18 years of age\n* patients scheduled for elective major thoracic procedure (lung resection, pleurectomy or resection of the esophagus)\n* planned thoracotomy and intraoperative period of one lung ventilation\n* planned postoperative admission to the ICU\n\nExclusion criteria:\n\n* persistent atrial fibrillation\n* structural heart defects (shunting or moderate to severe valvular anomalies)\n* preoperative serum hemoglobin levels \\< 120 g/L\n* severe heart failure classified as New York Heart Association (NYHA) grade IV'}, 'identificationModule': {'nctId': 'NCT05615168', 'briefTitle': 'Use of Hypotension Prediction Index to Reduce Intraoperative Hypotension in Major Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Dubrava'}, 'officialTitle': 'Use of Hypotension Prediction Index to Reduce Intraoperative Hypotension in Major Thoracic Surgery', 'orgStudyIdInfo': {'id': '2022/1807-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AcumenIQ - HPI guided hemodynamic optimization', 'description': 'HPI guided hypotension prediction alarms... Interventions based on SVV (fluid), dp/dt (inotropes), EAdyn (pressors)', 'interventionNames': ['Diagnostic Test: "Acumen IQ" guided hemodynamic optimization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flotrac - conventional GDT guided hemodynamic optimization', 'description': 'GDT guided hemodynamic optimization - MAP \\> 65 mmHg, CI ≥ 2.4 l/min/m2, SVI ≥ 30 ml/beat/m2 and SVRI 1700-2400 dyn·s·cm-5/m2', 'interventionNames': ['Diagnostic Test: "Flotrac" guided hemodynamic optimization']}], 'interventions': [{'name': '"Acumen IQ" guided hemodynamic optimization', 'type': 'DIAGNOSTIC_TEST', 'description': 'Hypotension prediction index (HPI) available with the Edwards "Acumen IQ" sensor will be used as an early warning system and a "diagnostic screen" will be used to guide therapeutic interventions.', 'armGroupLabels': ['AcumenIQ - HPI guided hemodynamic optimization']}, {'name': '"Flotrac" guided hemodynamic optimization', 'type': 'DIAGNOSTIC_TEST', 'description': 'Therapeutic interventions guided by real time monitored hemodynamic parameters as measured by Edwards "Flotrac" sensor.', 'armGroupLabels': ['Flotrac - conventional GDT guided hemodynamic optimization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Zagreb', 'state': 'City of Zagreb', 'country': 'Croatia', 'facility': 'University Hospital Dubrava', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Will share anonymized data after article publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Dubrava', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal investigator, Head of division of cardiovascular anesthesiology', 'investigatorFullName': 'Andrej Šribar', 'investigatorAffiliation': 'University Hospital Dubrava'}}}}