Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-01-05 @ 12:25 AM
Study NCT ID:
NCT02893657
Status:
UNKNOWN
Last Update Posted:
2022-01-11
First Post:
2016-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role and Dynamics of Liver Dysfunction in Patients Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '5 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-07', 'studyFirstSubmitDate': '2016-08-30', 'studyFirstSubmitQcDate': '2016-09-02', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The composite of in-hospital death of any cause', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'Length of ICU stay', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}], 'secondaryOutcomes': [{'measure': 'Evidence of clinically definite postoperative decline in hepatic function', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'Need for reoperation due to bleeding or cardiac cause', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'Evidence of clinically definite postoperative pulmonary or systemic congestion', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'Evidence of clinically definite postoperative low cardiac output syndrome', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'Evidence of clinically definite postoperative acute kidney injury and the need for dialysis', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'Evidence of clinically definite postoperative impaired coagulation', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MELD score', 'hemodynamics', 'liver abnormalities'], 'conditions': ['Cardiac Surgery', 'Hepatic Impairment', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is the evaluation of the occurrence and effect of hepatic dysfunction on outcome following cardiac surgery, as well as the monitoring of changes in liver haemodynamics in the early postoperative period.', 'detailedDescription': 'Prospective, consecutive study of patients undergoing cardiac surgery in Heart and Vascular Center, Semmelweis University, Budapest.\n\nRegistered data:\n\n* Anamnestic and demographic data\n* Liver dysfunction prior surgery, etiology of liver dysfunction\n* Perioperative clinical data: laboratory tests, imaging, haemodynamic measures\n* risk prediction score of the American Society of Anesthesiologists(ASA), EUROpean System for Cardiac Operative Risk Evaluation (EuroScore), Acute Physiology and Chronic Health Evaluation II (APACHE II), Simplified Acute Physiology Score (SAPS II), Canadian Cardiovascular Society grading of angina pectoris (CCS)\n* Model for End-Stage Liver Disease (MELD), MELD excluding International Normalised Ratio (INR) (MELD-XI), modified MELD score (modMELD), Child-Pugh\n\nThe occurrence and etiology pattern of hepatic impairment are going to be evaluated according to age and type of cardiac illness. Correlations between perioperative haemodynamical alterations and structural, functional changes in hepatic status will be investigated.\n\nThe impact of hepatic impairment on surgical outcome is going to be examined by multivariate regression models.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult cardiac surgical patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age admitted for elective cardiac surgical procedures\n\nExclusion Criteria:\n\n* Not willing to participate.\n* Pregnant women.\n* During active psychiatric hospital care.\n* Patients with defined legal incapability or limited capability.\n* Non-evaluable patient due to insufficient clinical information\n* Patients with a transplanted heart.'}, 'identificationModule': {'nctId': 'NCT02893657', 'briefTitle': 'The Role and Dynamics of Liver Dysfunction in Patients Undergoing Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Semmelweis University Heart and Vascular Center'}, 'officialTitle': 'The Role and Dynamics of Liver Dysfunction in Patients Undergoing Cardiac Surgery', 'orgStudyIdInfo': {'id': 'SE AITK VSZÉK LIVER'}}, 'contactsLocationsModule': {'locations': [{'zip': '1122', 'city': 'Budapest', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Andrea Szekely, MD, PhD', 'role': 'CONTACT', 'email': 'andi_szekely@yahoo.com', 'phone': '0036206632243'}], 'facility': 'Heart and Vascular Center, Semmelweis University', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'centralContacts': [{'name': 'Andrea Székely, MD, PhD', 'role': 'CONTACT', 'email': 'andi_szekely@yahoo.com', 'phone': '+36206632243'}, {'name': 'Enikő Holndonner-Kirst, MD', 'role': 'CONTACT', 'email': 'kirst.eniko@gmail.com', 'phone': '+36305058050'}], 'overallOfficials': [{'name': 'Enikő Holndonner-Kirst, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Semmelweis University'}, {'name': 'Andrea Székely, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Semmelweis University'}, {'name': 'Daniel Lex, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Semmelweis University'}, {'name': 'Nikoletta Ráhel Czobor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Semmelweis University'}, {'name': 'Ádám Nagy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Semmelweis University'}, {'name': 'János Gál, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Semmelweis University'}, {'name': 'Béla Merkely, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Semmelweis University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Semmelweis University Heart and Vascular Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Semmelweis University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Andrea Szekely', 'investigatorAffiliation': 'Semmelweis University'}}}}