Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT03522194
Status:
COMPLETED
Last Update Posted:
2019-03-12
First Post:
2018-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Left Ventricular Diastolic Function During Anesthesia Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-10', 'studyFirstSubmitDate': '2018-04-30', 'studyFirstSubmitQcDate': '2018-04-30', 'lastUpdatePostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Norepinephrine', 'timeFrame': '30 minutes after induction of anesthesia', 'description': 'Cumulative dose of norepinephrine (adjusted for body weight) during the first 30 minutes after induction of anesthesia'}], 'secondaryOutcomes': [{'measure': "e'", 'timeFrame': 'Directly after induction of anesthesia', 'description': "Change of the echocardiographic tissue doppler parameter e' after induction of anesthesia"}, {'measure': "E / e'", 'timeFrame': 'Directly after induction of anesthesia', 'description': 'Change of the echocardiographic index of transmitral flow and tissue doppler after induction of anesthesia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Left Ventricular Diastolic Dysfunction']}, 'referencesModule': {'references': [{'pmid': '33264119', 'type': 'DERIVED', 'citation': 'Kahl U, Vens M, Pollok F, Menke M, Duckstein C, Gruetzmacher J, Schirren L, Yu Y, Fischer M, Zollner C, Goepfert MS, Roeher K. Do Elderly Patients With Diastolic Dysfunction Require Higher Doses of Norepinephrine During General Anesthesia for Noncardiac Surgeries? A Prospective Observational Study. Anesth Analg. 2021 Feb 1;132(2):420-429. doi: 10.1213/ANE.0000000000005304.'}]}, 'descriptionModule': {'briefSummary': 'Diastolic dysfunction is an important cause of hemodynamic instability in the perioperative field.Therefore this study aims to investigate the influence of existing diastolic dysfunction or deterioration of diastolic function on hemodynamic stability during induction of anesthesia and postoperative complications. The impact of different anesthetics on diastolic function is investigated.', 'detailedDescription': 'In this prospective observational study two cohorts of patients with different anesthesia regimes are investigated. Anesthesia is maintained with sevoflurane or propofol. Before induction of anesthesia a transthoracic echocardiography is performed to examine systolic and diastolic function. Immediately after induction, during maintenance and after completion of anesthesia any changes of diastolic function are examined with transthoracic echocardiography. All anesthetic medications, fluids, vasoactive medications and catecholamines are registered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients scheduled for surgery under general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 60 years scheduled for general anesthesia\n\nExclusion Criteria:\n\n* Mitral regurgitation or stenosis \\> I°\n* Sp. mitral valve repair or replacement\n* Pericardial effusion\n* Atrial fibrillation/flutter\n* Patients with pacemaker\n* BMI \\> 35 kg/m2'}, 'identificationModule': {'nctId': 'NCT03522194', 'briefTitle': 'Left Ventricular Diastolic Function During Anesthesia Induction', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Influence of Left Ventricular Diastolic Function on Hemodynamic Stability During Anesthesia Induction and on Postoperative Complications', 'orgStudyIdInfo': {'id': 'PV 5436'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sevoflurane', 'description': 'Anesthesia maintenance', 'interventionNames': ['Drug: Sevoflurane']}, {'label': 'Propofol', 'description': 'Anesthesia maintenance', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'Anesthesia maintenance with Sevoflurane', 'armGroupLabels': ['Sevoflurane']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'Anesthesia maintenance with Propofol', 'armGroupLabels': ['Propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Katharina Roeher, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}