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

• Conditions: Heart Failure; Cardiac Surgery; Hepatic Impairment

• Registration Number: NCT02893657
• Lead Sponsor: Semmelweis University Heart and Vascular Center

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.

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 Timeline

• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-09-02
• Study First Posted: 2016-09-08
• Study Start: 2017-12-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 ICU stay	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

Secondary Outcome Measures

Name	Time	Method
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 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
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

Trial Locations

Locations (1)

Heart and Vascular Center, Semmelweis University; 🇭🇺 Budapest, Hungary