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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Cardiac Surgery; Hepatic Impairment

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Andrea Székely, MD, PhD; Phone Number: +36206632243; Email: andi_szekely@yahoo.com
• Study Contact Backup: Name: Enikő Holndonner-Kirst, MD; Phone Number: +36305058050; Email: kirst.eniko@gmail.com

Study Locations

• Hungary
  • Budapest, Hungary, 1122
    • Recruiting
    • Heart and Vascular Center, Semmelweis University
    • Contact: Andrea Szekely, MD, PhD; Phone Number: 0036206632243; Email: andi_szekely@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult cardiac surgical patients

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Length of hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of ICU stay	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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
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
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
Evidence of clinically definite postoperative impaired coagulation	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Collaborators and Investigators

• Sponsor: Semmelweis University Heart and Vascular Center
• Collaborators: Semmelweis University
• Investigators: Principal Investigator: Eniko 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 record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 2, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: hemodynamics; MELD score; liver abnormalities
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: SE AITK VSZÉK LIVER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No