Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT01166360
Status:
COMPLETED
Last Update Posted:
2011-03-15
First Post:
2010-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Usefulness of Growth Differentiation Factor 15 (GDF-15) for Risk Stratification in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma and urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-14', 'studyFirstSubmitDate': '2010-07-20', 'studyFirstSubmitQcDate': '2010-07-20', 'lastUpdatePostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30 day mortality', 'timeFrame': '30 days', 'description': 'The predictive accuracy of GDF-15 will be compared with the Euroscore. Since the Euroscore has been calibrated for 30 day mortality, this time frame will be used as primary outcome parameter.'}], 'secondaryOutcomes': [{'measure': '1 year mortality', 'timeFrame': '365 days', 'description': '1 year mortality is a more relevant outcome variable than 30 day mortality'}, {'measure': 'Renal dysfunction defined according to AKI-criteria', 'timeFrame': '30 days', 'description': 'Renal dysfunction is an important outcome variable in cardiac surgery.'}, {'measure': 'MaC score as combined measure of postoperative morbidity', 'timeFrame': '30 days', 'description': 'The MACS is a combined score for postoperative complications: low cardiac output syndrome, need for renal replacement therapy, stroke, reintubation.'}, {'measure': 'Sensitive markers of organ dysfunction', 'timeFrame': '4 days', 'description': 'Fatty acid binding protein, neutrophyil gelatinase associated lipocalin are sensitive markers of organ dysfunction and shall be used to give more precise information on organ dysfunction.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Risk prediction', 'Euroscore', 'GDF-15', 'hsTnT', 'cardiac surgery'], 'conditions': ['Heart Failure', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '27717384', 'type': 'DERIVED', 'citation': 'Heringlake M, Charitos EI, Erber K, Berggreen AE, Heinze H, Paarmann H. Preoperative plasma growth-differentiation factor-15 for prediction of acute kidney injury in patients undergoing cardiac surgery. Crit Care. 2016 Oct 8;20(1):317. doi: 10.1186/s13054-016-1482-3.'}, {'pmid': '23391200', 'type': 'DERIVED', 'citation': 'Heringlake M, Charitos EI, Gatz N, Kabler JH, Beilharz A, Holz D, Schon J, Paarmann H, Petersen M, Hanke T. Growth differentiation factor 15: a novel risk marker adjunct to the EuroSCORE for risk stratification in cardiac surgery patients. J Am Coll Cardiol. 2013 Feb 12;61(6):672-81. doi: 10.1016/j.jacc.2012.09.059.'}]}, 'descriptionModule': {'briefSummary': 'Growth determination factor 15 (GDF-15) and high sensitive troponin-t (hsTnT) are emerging humoral markers for risk stratification in clinically stable heart failure patients and in patients with stable coronary artery disease. No data are available about the prognostic value of these peptides in relation to mortality and morbidity in patients undergoing cardiac surgery.\n\nPrimary objective of the present study is to test the hypothesis, that GDF-15 is superior to a standard preoperative risk score, the additive Euroscore for the prediction of 30 day mortality and postoperative morbidity in patients scheduled for cardiac surgery.\n\nSecondary objectives are to test the predictive value of hsTNT, either alone, or in combination with GDF-15 and if GDF-15 adds additional information to NTproBNP levels and preoperative cerebral oxygen saturation (ScO2) levels.', 'detailedDescription': 'The study will be based on 2 patient cohorts, a group of patients studied during an observation period (2009) and a validation cohort of patients studied in 2008. The 2009 cohort (about 800 patients) will be analyzed to determine the predictive value of GDF-15 for predicting mortality and morbidity. The 2008 cohort (about 1200 patients) will be used to validate these findings.\n\nBesides conventional morbidity markers, new sensitive markers of organ dysfunction (FABP, NGAL, sFLT-1, PIGF) will also be tested in the 2009 group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients undergoing primary cardiac surgery at a University hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for cardiac surgery\n\nExclusion Criteria:\n\n* Withdrawal of informed consent'}, 'identificationModule': {'nctId': 'NCT01166360', 'briefTitle': 'The Usefulness of Growth Differentiation Factor 15 (GDF-15) for Risk Stratification in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'The Prognostic Relevance of Cerebral Oxygen Saturation, NTproBNP and Preoperative Creatinine Clearance in Cardiac Surgical Patients; Amendment 4: the Prognostic Relevance of Growth Differentiation Factor 15 (GDF-15) and High Sensitive Troponin-t (hsTnT)', 'orgStudyIdInfo': {'id': 'CS_RS_2008-2009 - GDF_TNT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients 2009', 'description': 'Patients undergoing cardiac surgery in 2009'}, {'label': 'Patients 2008', 'description': 'Patients undergoing cardiac surgery in 2008'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23568', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Department of Anesthesiology, University of Luebeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'overallOfficials': [{'name': 'Matthias Heringlake, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, University of Luebeck'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Luebeck', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Dr. med. Matthias Heringlake', 'oldOrganization': 'Department of Anesthesiology, University of Luebeck'}}}}