Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-02-02 @ 9:20 PM
Study NCT ID:
NCT01918618
Status:
COMPLETED
Last Update Posted:
2013-08-08
First Post:
2013-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Effects of Levosimendan in Cardiac Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2013-07-26', 'studyFirstSubmitQcDate': '2013-08-06', 'lastUpdatePostDateStruct': {'date': '2013-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of plasma creatinine (Difference in renal function)', 'timeFrame': 'last available value pre-op (baseline), first available value on post-op day 1, 2, 3 and 4', 'description': 'Only in patients not requiring renal replacement therapy'}, {'measure': 'Change of urine output after surgery (difference in renal function)', 'timeFrame': 'post-op day 1, 2, 3, 4', 'description': 'Only in patients not requiring renal replacement therapy'}, {'measure': 'Cumulative incidence and duration of hemodialysis (Difference in renal function)', 'timeFrame': 'last day of hospital stay'}], 'secondaryOutcomes': [{'measure': 'Cumulative Length of stay (hospital and ICU)', 'timeFrame': 'last day of hospital stay'}, {'measure': 'In-hospital mortality', 'timeFrame': 'last day of hospital stay'}]}, 'conditionsModule': {'keywords': ['levosimendan', 'renal effects', 'cardiac surgery', 'left heart insufficiency'], 'conditions': ['Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '17331245', 'type': 'BACKGROUND', 'citation': 'Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.'}, {'pmid': '18056154', 'type': 'BACKGROUND', 'citation': 'Yakut N, Yasa H, Bahriye Lafci B, Ortac R, Tulukoglu E, Aksun M, Ozbek C, Gurbuz A. The influence of levosimendan and iloprost on renal ischemia-reperfusion: an experimental study. Interact Cardiovasc Thorac Surg. 2008 Apr;7(2):235-9. doi: 10.1510/icvts.2007.161356. Epub 2007 Dec 3.'}, {'pmid': '25399779', 'type': 'DERIVED', 'citation': 'Balzer F, Treskatsch S, Spies C, Sander M, Kastrup M, Grubitzsch H, Wernecke KD, Braun JP. Early administration of levosimendan is associated with improved kidney function after cardiac surgery - a retrospective analysis. J Cardiothorac Surg. 2014 Nov 18;9:167. doi: 10.1186/s13019-014-0167-8.'}]}, 'descriptionModule': {'briefSummary': 'Recent experimental and clinical data suggest a benefit of levosimendan on the kidney function. Therefore, this retrospective, single center, matched-pairs analysis aimed to investigate whether administration of levosimendan was associated with improved renal function in cardiac surgery patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cardiac surgery between 2007 and 2011 followed by postoperative observation on an ICU of the anaesthesiology department of the Charité hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing cardiac surgery (OPS 5-35 bis 5-37) between 2007 and 2011 followed by postoperative observation on an ICU of the anaesthesiology department of the Charité hospital\n\nExclusion Criteria:\n\n* Patients younger 18\n* Preexisting renal insufficiency'}, 'identificationModule': {'nctId': 'NCT01918618', 'briefTitle': 'Renal Effects of Levosimendan in Cardiac Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'orgStudyIdInfo': {'id': 'EA1-044-13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Levosimendan', 'description': 'study group'}, {'label': 'No Levosimendan', 'description': 'Control group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Charité - University Medicine Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'Jan Braun, MD', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}