Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:20 PM
Study NCT ID:
NCT02655094
Status:
COMPLETED
Last Update Posted:
2017-06-06
First Post:
2015-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Unilateral Pulmonary Edema After Minimal-invasive Mitral Valve Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011654', 'term': 'Pulmonary Edema'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-03', 'studyFirstSubmitDate': '2015-12-05', 'studyFirstSubmitQcDate': '2016-01-11', 'lastUpdatePostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Unilateral right sided pulmonary edema or congestion after surgery', 'timeFrame': 'Postoperatively within the first 12h after admission to intensive care unit', 'description': 'retrospective analysis using the electronic and the paper-based patient specific database'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['minimal-invasive surgery, mitral valve'], 'conditions': ['Pulmonary Edema']}, 'referencesModule': {'references': [{'pmid': '29186375', 'type': 'DERIVED', 'citation': 'Renner J, Lorenzen U, Borzikowsky C, Schoeneich F, Cremer J, Haneya A, Hensler J, Panholzer B, Huenges K, Broch O. Unilateral pulmonary oedema after minimally invasive mitral valve surgery: a single-centre experience. Eur J Cardiothorac Surg. 2018 Apr 1;53(4):764-770. doi: 10.1093/ejcts/ezx399.'}]}, 'descriptionModule': {'briefSummary': 'Unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some cases severe complications, sometimes causing extracorporeal life support. The investigators have observed over several years 5 cases of instantaneous postoperative severe pulmonary edema. This is a retrospective analysis of over 200 minimal-invasive mitral valve surgery procedure.', 'detailedDescription': 'Unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some cases severe complications, sometimes causing extracorporeal life support. The investigators have observed over several years 5 cases of instantaneous postoperative severe pulmonary edema. After having studied the available literature on this particular topic the investigators have decided to prepare a retrospective analysis of over 200 minimal-invasive mitral valve surgery procedure focusing on radiological and clinical signs of unilateral pulmonary edema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Collective of patients with relevant mitral valve disease scheduled for minimal-invasive mitral valve repair or replacement', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>= 18 years of age\n\nExclusion Criteria:\n\n* urgent surgery'}, 'identificationModule': {'nctId': 'NCT02655094', 'briefTitle': 'Unilateral Pulmonary Edema After Minimal-invasive Mitral Valve Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'officialTitle': 'Unilateral Pulmonary Edema After Minimal-invasive Mitral Valve Surgery: a Retrospective Single Center Observation', 'orgStudyIdInfo': {'id': 'IN-MIC-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'universitätsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'Jochen Renner, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Schleswig-Holstein'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr.', 'investigatorFullName': 'Dr. Jochen Renner', 'investigatorAffiliation': 'University Hospital Schleswig-Holstein'}}}}