Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 11:57 AM
Study NCT ID:
NCT02441751
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2015-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Volume Management and QT Interval
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016063', 'term': 'Blood Loss, Surgical'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-30', 'studyFirstSubmitDate': '2015-05-08', 'studyFirstSubmitQcDate': '2015-05-11', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in QT-time', 'timeFrame': 'during operation'}], 'secondaryOutcomes': [{'measure': 'postoperative incidents/disturbance rhythm of the heart', 'timeFrame': '2 days', 'description': 'association to intraoperative repolarisation-disturbance / QT-prolongation'}, {'measure': 'survival', 'timeFrame': '1 year', 'description': 'association to intraoperative repolarisation-disturbance / QT-prolongation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Electrocardiography', 'Hemorrhage', 'Monitoring, Intraoperative'], 'conditions': ['Blood Loss, Surgical']}, 'referencesModule': {'references': [{'pmid': '16412861', 'type': 'BACKGROUND', 'citation': 'Straus SM, Kors JA, De Bruin ML, van der Hooft CS, Hofman A, Heeringa J, Deckers JW, Kingma JH, Sturkenboom MC, Stricker BH, Witteman JC. Prolonged QTc interval and risk of sudden cardiac death in a population of older adults. J Am Coll Cardiol. 2006 Jan 17;47(2):362-7. doi: 10.1016/j.jacc.2005.08.067.'}]}, 'descriptionModule': {'briefSummary': 'QT interval changes is measured during all phases of the operation. The protocol is focusing at intraoperative bleeding events and is also observing QT interval changes during anesthetic and operative procedures.', 'detailedDescription': 'Prolongation of the QT interval is associated with functional torsade de points, re-entry, and sudden death (see reference). Variations of QT-interval caused by changes in the volume status of the patient during an operation remained unclear. QT interval changes will be monitored during the surgery with the focus of the influence of sudden blood loss, volume substitution by crystalloids, blood and blood products. The effect of surgical procedures on the QT-interval (e.g. clamping of kidney artery) will be observed as well as the association of intra-operative QT-interval alterations with postoperative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients for major surgery in urology and orthopedics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical status classification 2 - 3\n* patients after consent\n\nExclusion Criteria:\n\n* Children,\n* pregnant women,\n* patients not able to consent'}, 'identificationModule': {'nctId': 'NCT02441751', 'briefTitle': 'Intraoperative Volume Management and QT Interval', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Intraoperative Repolarisation - Etiology and Relevance for the Decision Making by Anesthesiologists in the Management of Volume Substitution and Transfusion', 'orgStudyIdInfo': {'id': 'EK110032015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'bleeding', 'description': 'intraoperative blood loss \\> 500 ml', 'interventionNames': ['Procedure: intra-operative blood loss']}, {'label': 'no bleeding', 'description': 'intraoperative blood loss \\< 500 ml'}], 'interventions': [{'name': 'intra-operative blood loss', 'type': 'PROCEDURE', 'description': 'surgery in the urology and orthopedics', 'armGroupLabels': ['bleeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Torsten Richter, M.D.', 'role': 'CONTACT', 'email': 'torsten.richter@uniklinikum-dresden.de', 'phone': '004935145818034'}], 'facility': 'Dept. of Anesthesia and Intensive Care, University Hospital, Technische Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'centralContacts': [{'name': 'Torsten Richter, M.D.', 'role': 'CONTACT', 'email': 'torsten.richter@uniklinikum-dresden.de', 'phone': '004935145818034'}, {'name': 'Juliane Flaxa, M.D.', 'role': 'CONTACT', 'email': 'juliane.flaxa@uniklinikum-dresden.de', 'phone': '0049351458', 'phoneExt': '2785'}], 'overallOfficials': [{'name': 'Torsten Richter, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Dresden, TU Dresden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}