Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-04-18 @ 6:54 AM
Study NCT ID:
NCT01773720
Status:
UNKNOWN
Last Update Posted:
2013-01-23
First Post:
2013-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability of Cardiac Output Monitoring Based on Uncalibrated Pulse Contour Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-11-18', 'releaseDate': '2022-04-07'}], 'estimatedResultsFirstSubmitDate': '2022-04-07'}}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'No biospecimens are to be retained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-18', 'studyFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2013-01-18', 'lastUpdatePostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity of cardiac index measurement', 'timeFrame': 'Up to 24 hrs post surgery', 'description': 'Accuracy and precision of cardiac index measurement using uncalibrated pulse contour analysis in comparison with transpulmonary thermodilution'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiac index', 'coronary artery bypass', 'uncalibrated pulse contour analysis', 'hemodynamic monitoring'], 'conditions': ['Cardiac Index']}, 'referencesModule': {'references': [{'pmid': '24531685', 'type': 'DERIVED', 'citation': 'Smetkin AA, Hussain A, Kuzkov VV, Bjertnaes LJ, Kirov MY. Validation of cardiac output monitoring based on uncalibrated pulse contour analysis vs transpulmonary thermodilution during off-pump coronary artery bypass grafting. Br J Anaesth. 2014 Jun;112(6):1024-31. doi: 10.1093/bja/aet489. Epub 2014 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'The aim of our study was to evaluate the reliability of uncalibrated cardiac index monitoring based on arterial waveform analysis in patients undergoing off-pump coronary artery bypass grafting.', 'detailedDescription': 'Using contemporary statistical method the cardiac index values obtained via uncalibrated pulse contour analysis with Pro AQT system will be compared with traditional transpulmonary thermodilution technique (Pulsion, Germany).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary artery disease, ranked ASA II-III and scheduled for elective off-pump coronary artery bypass grafting', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective off-pump coronary artery bypass grafting\n\nExclusion Criteria:\n\n* age \\< 18 and \\> 80 years,\n* preoperative ejection fraction \\< 0.35,\n* severe cardiac valve dysfunction or peripheral vascular disease,\n* constant atrial fibrillation,\n* simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.),\n* transfer to cardiopulmonary bypass.'}, 'identificationModule': {'nctId': 'NCT01773720', 'briefTitle': 'Reliability of Cardiac Output Monitoring Based on Uncalibrated Pulse Contour Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Northern State Medical University'}, 'officialTitle': 'Evaluation of Reliability of Cardiac Output Monitoring Based on Uncalibrated Pulse Contour Analysis During Off-pump Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': 'UncalPCA-vs-TPTD'}}, 'contactsLocationsModule': {'locations': [{'zip': '163000', 'city': 'Arkhangelsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Mikhail Y Kirov, MD, PhD', 'role': 'CONTACT', 'email': 'mikhail_kirov@hotmail.com', 'phone': '+7-8182-63-27-30'}, {'name': 'Alexey A Smetkin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mikhail Y Kirov, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ayyaz Hussain, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Vsevolod V Kuzkov, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lars J Bjertnæs, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Dep. of Anesthesiology, Northern SMU', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}], 'centralContacts': [{'name': 'Mikhail Y Kirov, MD, PhD', 'role': 'CONTACT', 'email': 'mikhail_kirov@hotmail.com', 'phone': '+7-8182-63-27-30'}], 'overallOfficials': [{'name': 'Mikhail Y Kirov, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Northern State Medical Univercity'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northern State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-04-07', 'type': 'RELEASE'}, {'date': '2022-11-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Northern State Medical University'}}}}