Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 9:18 PM
Study NCT ID:
NCT02156856
Status:
UNKNOWN
Last Update Posted:
2014-08-08
First Post:
2014-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stroke Volume Analysis During Aortic Valve Replacement Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-07', 'studyFirstSubmitDate': '2014-05-20', 'studyFirstSubmitQcDate': '2014-06-02', 'lastUpdatePostDateStruct': {'date': '2014-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'oxygen delivery (ml)', 'timeFrame': 'Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'image quality of echocardiography', 'timeFrame': 'Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'Length of stay on ICU', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'Cumulative rate of infections', 'timeFrame': 'after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'incidence of delirium after surgery', 'timeFrame': 'after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'dosage of inotropic medication (mg/d)', 'timeFrame': 'after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'length of hospital stay', 'timeFrame': 'after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'incidence of stroke', 'timeFrame': 'after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}], 'primaryOutcomes': [{'measure': 'Measurement of stroke volume (ml) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter', 'timeFrame': 'Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'Measurement of cardiac output (l/min) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter', 'timeFrame': 'Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}], 'secondaryOutcomes': [{'measure': 'Measurement of stroke volume (ml) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter', 'timeFrame': 'After surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'Accordance of stroke volume and cardiac output measurements assessed by (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter AFTER ADMINISTRATION OF FLUID BOLUS', 'timeFrame': 'Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'Accordance of stroke volume and cardiac output measurements assessed by two of the mentioned methods [i.e. (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter]', 'timeFrame': 'Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'Measurement of cardiac output (l/min) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter', 'timeFrame': 'After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hemodynamic monitoring', 'cardiac output', 'cardiac surgery'], 'conditions': ['Hemodynamic Monitoring', 'Cardiac Output', 'Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome, mainly due to post-operative infections or heart failure. Insufficient stroke volume and/or cardiac output due to hypovolemia or cardiac defects play a central role in causing poor peripheral tissue oxygenation. In order to assess stroke volume, there are numerous invasive and non-invasive methods available. Up to the present date it is unknown, if these methods may by used interchangeably in patients with severe cardiac defects like aortic stenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cardiac surgery at a university hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled transcatheter aortic valve implantation\n* signed patient consent form\n* aged 18 or older by time of surgery\n* no participation in other clinical trials\n\nExclusion Criteria:\n\n* pregnant or breast-feeding women\n* emergency surgery'}, 'identificationModule': {'nctId': 'NCT02156856', 'acronym': 'standart', 'briefTitle': 'Stroke Volume Analysis During Aortic Valve Replacement Trial', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'orgStudyIdInfo': {'id': 'EA1/060/13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hemodynamic optimisation'}, {'label': 'No hemodynamic optimisation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Sander, MD', 'role': 'CONTACT', 'email': 'michael.sander@charite.de', 'phone': '+4930450531052'}, {'name': 'Sascha Treskatsch, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marit Habicher, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Viktor Mezger, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Felix Balzer, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Charité Universitätsmedizin Berin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Michael Sander, MD', 'role': 'CONTACT', 'email': 'michael.sander@charite.de', 'phone': '+4930450531052'}], 'overallOfficials': [{'name': 'Michael Sander, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ.-Prof. Dr. med.', 'investigatorFullName': 'Michael Sander', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}