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The Role and Dynamics of Liver Dysfunction in Patients Undergoing Cardiac Surgery

Sponsor
Semmelweis University Heart and Vascular Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02893657
Collaborator
Semmelweis University (Other)
150
Enrollment
1
Location
65
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Prospective, consecutive study of patients undergoing cardiac surgery in Heart and Vascular Center, Semmelweis University, Budapest.

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Role and Dynamics of Liver Dysfunction in Patients Undergoing Cardiac Surgery
    Actual Study Start Date :
    Dec 1, 2017
    Anticipated Primary Completion Date :
    May 1, 2022
    Anticipated Study Completion Date :
    May 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. The composite of in-hospital death of any cause [Participants will be followed for the duration of hospital stay, an expected average of 2 weeks]

    2. Length of hospital stay [Participants will be followed for the duration of hospital stay, an expected average of 2 weeks]

    3. Length of ICU stay [Participants will be followed for the duration of hospital stay, an expected average of 2 weeks]

    Secondary Outcome Measures

    1. Evidence of clinically definite postoperative decline in hepatic function [Participants will be followed for the duration of hospital stay, an expected average of 2 weeks]

    2. Need for reoperation due to bleeding or cardiac cause [Participants will be followed for the duration of hospital stay, an expected average of 2 weeks]

    3. Evidence of clinically definite postoperative pulmonary or systemic congestion [Participants will be followed for the duration of hospital stay, an expected average of 2 weeks]

    4. Evidence of clinically definite postoperative low cardiac output syndrome [Participants will be followed for the duration of hospital stay, an expected average of 2 weeks]

    5. Evidence of clinically definite postoperative acute kidney injury and the need for dialysis [Participants will be followed for the duration of hospital stay, an expected average of 2 weeks]

    6. Evidence of clinically definite postoperative impaired coagulation [Participants will be followed for the duration of hospital stay, an expected average of 2 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients over 18 years of age admitted for elective cardiac surgical procedures
    Exclusion Criteria:

    • Not willing to participate.

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Heart and Vascular Center, Semmelweis University Budapest Hungary 1122

    Sponsors and Collaborators

    • Semmelweis University Heart and Vascular Center
    • Semmelweis University

    Investigators

    • Principal Investigator: Enikő Holndonner-Kirst, MD, Semmelweis University
    • Study Director: Andrea Székely, MD, PhD, Semmelweis University
    • Principal Investigator: Daniel Lex, MD, Semmelweis University
    • Principal Investigator: Nikoletta Ráhel Czobor, MD, Semmelweis University
    • Principal Investigator: Ádám Nagy, MD, Semmelweis University
    • Study Chair: János Gál, MD, PhD, Semmelweis University
    • Study Chair: Béla Merkely, MD, PhD, Semmelweis University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrea Szekely, associate professor, Semmelweis University
    ClinicalTrials.gov Identifier:
    NCT02893657
    Other Study ID Numbers:
    • SE AITK VSZÉK LIVER
    First Posted:
    Sep 8, 2016
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Andrea Szekely, associate professor, Semmelweis University
    MELD score
    hemodynamics
    liver abnormalities
    Additional relevant MeSH terms:
    Liver Diseases

    Study Results

    No Results Posted as of Jan 11, 2022