Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-03-08 @ 11:01 PM
Study NCT ID:
NCT02322567
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2014-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Left Ventricular Diastolic Dysfunction in Kidney Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008499', 'term': 'Medical Records'}], 'ancestors': [{'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-24', 'studyFirstSubmitDate': '2014-12-09', 'studyFirstSubmitQcDate': '2014-12-22', 'lastUpdatePostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Postoperative graft function (graft failure, acute rejection, graft loss, serum creatinine)', 'timeFrame': '30 days', 'description': 'graft failure, acute rejection, graft loss, serum creatinine'}], 'primaryOutcomes': [{'measure': 'Patients with postoperative cardiovascular complications', 'timeFrame': '30 days', 'description': 'acute myocardial infarction, ventricular fibrillation/tachycardia, cardiogenic shock, newly-onset atrial fibrillation, clinical pulmonary edema requiring endotracheal intubation or dialysis'}], 'secondaryOutcomes': [{'measure': 'Patients with postoperative pulmonary edema', 'timeFrame': '30 days', 'description': 'pulmonary edema by radiological evidence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Kidney Transplantation']}, 'referencesModule': {'references': [{'pmid': '27499694', 'type': 'DERIVED', 'citation': 'Kim EJ, Chang S, Kim SY, Huh KH, Kang S, Choi YS. Predictive Value of Echocardiographic Abnormalities and the Impact of Diastolic Dysfunction on In-hospital Major Cardiovascular Complications after Living Donor Kidney Transplantation. Int J Med Sci. 2016 Jul 18;13(8):620-8. doi: 10.7150/ijms.15745. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the relationship between pre-operative LV diastolic function and post-operative complications and kidney function in living-donor kidney transplantation patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elective kidney transplantation patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective kidney transplantation patients\n\nExclusion Criteria:\n\n* No data of preoperative echocardiography'}, 'identificationModule': {'nctId': 'NCT02322567', 'briefTitle': 'Left Ventricular Diastolic Dysfunction in Kidney Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Severance Hospital'}, 'officialTitle': 'Influence of Left Ventricular Diastolic Dysfunction on Graft Function and Postoperative Complication in Patients Undergoing Elective Kidney Transplantation', 'orgStudyIdInfo': {'id': '4-2014-0808'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LV diastolic dysfunction', 'interventionNames': ['Other: medical records']}, {'label': 'No LV diastolic dysfunction', 'interventionNames': ['Other: medical records']}], 'interventions': [{'name': 'medical records', 'type': 'OTHER', 'description': 'review of medical records', 'armGroupLabels': ['LV diastolic dysfunction', 'No LV diastolic dysfunction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yong Seon Choi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'So Yeon Kim', 'investigatorAffiliation': 'Severance Hospital'}}}}