The Role and Dynamics of Liver Dysfunction in Patients Undergoing Cardiac Surgery
NCT ID: NCT02893657
Last Updated: 2022-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2017-12-01
2023-05-31
Brief Summary
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Detailed Description
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Registered data:
* Anamnestic and demographic data
* Liver dysfunction prior surgery, etiology of liver dysfunction
* Perioperative clinical data: laboratory tests, imaging, haemodynamic measures
* 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)
* Model for End-Stage Liver Disease (MELD), MELD excluding International Normalised Ratio (INR) (MELD-XI), modified MELD score (modMELD), Child-Pugh
The 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.
The impact of hepatic impairment on surgical outcome is going to be examined by multivariate regression models.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant women.
* During active psychiatric hospital care.
* Patients with defined legal incapability or limited capability.
* Non-evaluable patient due to insufficient clinical information
* Patients with a transplanted heart.
18 Years
ALL
No
Sponsors
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Semmelweis University
OTHER
Semmelweis University Heart and Vascular Center
OTHER
Responsible Party
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Andrea Szekely
associate professor
Principal Investigators
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Enikő Holndonner-Kirst, MD
Role: PRINCIPAL_INVESTIGATOR
Semmelweis University
Andrea Székely, MD, PhD
Role: STUDY_DIRECTOR
Semmelweis University
Daniel Lex, MD
Role: PRINCIPAL_INVESTIGATOR
Semmelweis University
Nikoletta Ráhel Czobor, MD
Role: PRINCIPAL_INVESTIGATOR
Semmelweis University
Ádám Nagy, MD
Role: PRINCIPAL_INVESTIGATOR
Semmelweis University
János Gál, MD, PhD
Role: STUDY_CHAIR
Semmelweis University
Béla Merkely, MD, PhD
Role: STUDY_CHAIR
Semmelweis University
Locations
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Heart and Vascular Center, Semmelweis University
Budapest, , Hungary
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SE AITK VSZÉK LIVER
Identifier Type: -
Identifier Source: org_study_id
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