Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2026-01-04 @ 9:13 PM
Study NCT ID:
NCT03349593
Status:
COMPLETED
Last Update Posted:
2022-01-05
First Post:
2017-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Hypovolemia and Heart Failure in Non-cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020896', 'term': 'Hypovolemia'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-15', 'studyFirstSubmitDate': '2017-11-17', 'studyFirstSubmitQcDate': '2017-11-17', 'lastUpdatePostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypovolemia', 'timeFrame': 'One hour before surgery', 'description': 'Screening of preoperative level of venous return'}, {'measure': 'Heart failure', 'timeFrame': 'One hour before surgery', 'description': 'Screening of incidence of preoperative systolic and diastolic function'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart failure, diastolic dysfunction, venous return', 'Left ventricular filling pressures'], 'conditions': ['Hypovolemia', 'Heart Failure', 'Diastolic Dysfunction', 'Systolic Dysfunction', 'Venous; Return (Anomaly)']}, 'referencesModule': {'references': [{'pmid': '35382761', 'type': 'DERIVED', 'citation': 'Stenberg Y, Rhodin Y, Lindberg A, Aroch R, Hultin M, Wallden J, Myrberg T. Pre-operative point-of-care assessment of left ventricular diastolic dysfunction, an observational study. BMC Anesthesiol. 2022 Apr 5;22(1):96. doi: 10.1186/s12871-022-01642-4.'}]}, 'descriptionModule': {'briefSummary': 'Prevalence of biventricular function of the heart and preoperative level of venous return is not known in non-cardiac non-morbid obese population.\n\nThe aim of the study is to assess the preoperative function of the heart and status of hypovolemia on the day of surgery.', 'detailedDescription': 'Preoperative transthoracic echocardiography (TTE) is conducted in 100 individuals. Biventricular function (i.e. systolic and diastolic properties), left ventricular filling pressures and level of venous return are assessed by TTE.\n\nMoreover high-sensitive troponine I and Nt-proBNP, ECG are collected. Multiple echocardiographic parameters will be studied for feasibility in terms of preoperative assessment of the heart.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Electively scheduled individuals for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body mass index ≤ 35 kg/m2, electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.\n\nExclusion Criteria:\n\n* Not signed consent.'}, 'identificationModule': {'nctId': 'NCT03349593', 'briefTitle': 'Prevalence of Hypovolemia and Heart Failure in Non-cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Prevalence of Hypovolemia and Heart Failure in Non-cardiac Surgery', 'orgStudyIdInfo': {'id': '2016/361-31 II'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Preoperative transthoracic echocardiography'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97180', 'city': 'Luleå', 'country': 'Sweden', 'facility': 'Sunderby hospital', 'geoPoint': {'lat': 65.58415, 'lon': 22.15465}}], 'overallOfficials': [{'name': 'Tomi P Myrberg, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University, Norrbotten county concil'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Tomi Myrberg', 'investigatorAffiliation': 'Umeå University'}}}}