Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-28 @ 2:33 PM
Study NCT ID:
NCT01178866
Status:
COMPLETED
Last Update Posted:
2010-08-10
First Post:
2010-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laboratory Outcome Predictors in Coronary Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-09', 'studyFirstSubmitDate': '2010-08-09', 'studyFirstSubmitQcDate': '2010-08-09', 'lastUpdatePostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complicated clinical course after coronary artery bypass surgery', 'timeFrame': 'within the first 30 days after surgery', 'description': 'Complicated clinical course defined as death within the first 30 days after surgery or ICU stay more than 4 days.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['thoracic surgery', 'myocardial revascularization', 'left ventricular dysfunction', 'tissue perfusion', 'prognosis'], 'conditions': ['Left Ventricular Dysfunction', 'Coronary Artery Bypass Surgery', 'Tissue Hypoperfusion']}, 'referencesModule': {'references': [{'pmid': '11904655', 'type': 'BACKGROUND', 'citation': 'Mekontso-Dessap A, Castelain V, Anguel N, Bahloul M, Schauvliege F, Richard C, Teboul JL. Combination of venoarterial PCO2 difference with arteriovenous O2 content difference to detect anaerobic metabolism in patients. Intensive Care Med. 2002 Mar;28(3):272-7. doi: 10.1007/s00134-002-1215-8. Epub 2002 Feb 8.'}, {'pmid': '17134504', 'type': 'BACKGROUND', 'citation': 'Ranucci M, De Toffol B, Isgro G, Romitti F, Conti D, Vicentini M. Hyperlactatemia during cardiopulmonary bypass: determinants and impact on postoperative outcome. Crit Care. 2006;10(6):R167. doi: 10.1186/cc5113.'}, {'pmid': '16731152', 'type': 'BACKGROUND', 'citation': 'Ranucci M, Isgro G, Romitti F, Mele S, Biagioli B, Giomarelli P. Anaerobic metabolism during cardiopulmonary bypass: predictive value of carbon dioxide derived parameters. Ann Thorac Surg. 2006 Jun;81(6):2189-95. doi: 10.1016/j.athoracsur.2006.01.025.'}, {'pmid': '15025779', 'type': 'BACKGROUND', 'citation': 'Meregalli A, Oliveira RP, Friedman G. Occult hypoperfusion is associated with increased mortality in hemodynamically stable, high-risk, surgical patients. Crit Care. 2004 Apr;8(2):R60-5. doi: 10.1186/cc2423. Epub 2004 Jan 12.'}, {'pmid': '16159844', 'type': 'BACKGROUND', 'citation': 'Topkara VK, Cheema FH, Kesavaramanujam S, Mercando ML, Cheema AF, Namerow PB, Argenziano M, Naka Y, Oz MC, Esrig BC. Coronary artery bypass grafting in patients with low ejection fraction. Circulation. 2005 Aug 30;112(9 Suppl):I344-50. doi: 10.1161/CIRCULATIONAHA.104.526277.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate less employed markers of tissue hypoperfusion as venoarterial carbon dioxide partial pressure difference (ΔPCO2) and estimated respiratory quotient (eRQ) combined to other classically studied markers as predictive factors of complicated clinical course after cardiac surgery in patients with left ventricular dysfunction.', 'detailedDescription': 'Patients with left ventricular dysfunction are more susceptible to tissue hypoperfusion and presents more frequently both low cardiac output syndrome and systemic inflammatory response, what results in prolonged stay in intensive care unit (ICU), and higher mortality rates when compared to patients with normal ventricular function.\n\nThe early prediction of prolonged ICU stay through the detection of tissue hypoperfusion may improve the management of care and decrease morbidity of this particular group of patients. However, classic markers of tissue hypoxia as central venous saturation, base excess, lactate may not be predictors of outcome in cardiac surgery patients with left ventricular dysfunction.\n\nThe question addressed in this study is if less employed markers of tissue hypoperfusion as as venoarterial carbon dioxide partial pressure difference (ΔPCO2) and estimated respiratory quotient (eRQ) have predictive value of prolonged ICU stay in patients with left ventricular dysfunction submitted to coronary artery bypass surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults undergoing coronary artery bypass surgery requiring the use of CPB', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults\n* left ventricular dysfunction (ejection fraction \\< 50%)\n* patients undergoing coronary artery bypass surgery requiring the use of Cardiopulmonary Bypass (CPB)\n\nExclusion Criteria:\n\n* renal failure (creatinine clearance lower than 40 ml/min/m2),\n* hepatic dysfunction\n* endocrinologic disorders\n* pulmonary disease\n* uncontrolled diabetes mellitus\n* a history of fever or infection within the week before surgery\n* previous anemia (hemoglobin ≤ 10.0 g/dL)'}, 'identificationModule': {'nctId': 'NCT01178866', 'briefTitle': 'Laboratory Outcome Predictors in Coronary Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Markers of Tissue Perfusion as Predictors of Complicated Evolution in Patients With Left Ventricular Dysfunction Submitted to Coronary Artery Bypass Surgery', 'orgStudyIdInfo': {'id': 'HC517/04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clinical course', 'description': 'complicated course group (death within 30 days after surgery or ICU stay \\> 4 days) and uncomplicated course group (ICU stay ≤ 4 days).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Heart Institute, Hospital of Clinics, São Paulo University Medical School', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Thiana Yamaguti, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Institute, Hospital of Clinics, São Paulo University Medical School'}, {'name': 'José Otávio C. Auler Júnior, PhD/Chairman', 'role': 'STUDY_CHAIR', 'affiliation': 'Heart Institute, Hospital of Clinics, São Paulo University Medical School'}, {'name': 'Marilde A. Piccioni, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Heart Institute, Hospital of Clinics, São Paulo University Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Thiana Yamaguti/ Médica assistente da divisão de anestesiologia do InCor - HCFMUSP', 'oldOrganization': 'University of Sao Paulo'}}}}