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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02893657
• Other study ID #: SE AITK VSZÉK LIVER
• Status: Recruiting
• Start date: December 1, 2017
• Est. completion date: May 2023

Study information

• Verified date: January 2022
• Source: Semmelweis University Heart and Vascular Center
• Contact: Andrea Székely, MD, PhD
• Phone: +36206632243
• Email: andi_szekely[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2023
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery
• Heart Failure
• Hepatic Impairment
• Liver Diseases

Locations

Country	Name	City	State
Hungary	Heart and Vascular Center, Semmelweis University	Budapest

Sponsors (2)

Lead Sponsor	Collaborator
Semmelweis University Heart and Vascular Center	Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Length of hospital stay		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Primary	Length of ICU stay		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Evidence of clinically definite postoperative impaired coagulation		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks