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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02893657
Enrollment
150
Registered
2016-09-08
Start date
2017-12-01
Completion date
2023-05-31
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Heart Failure, Hepatic Impairment

Keywords

MELD score, hemodynamics, liver abnormalities

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.

Interventions

None listed

Sponsors

Semmelweis University
CollaboratorOTHER
Semmelweis University Heart and Vascular Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
The composite of in-hospital death of any causeParticipants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of hospital stayParticipants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of ICU stayParticipants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary

MeasureTime frame
Evidence of clinically definite postoperative low cardiac output syndromeParticipants will be followed for the duration of hospital stay, an expected average of 2 weeks
Evidence of clinically definite postoperative decline in hepatic functionParticipants will be followed for the duration of hospital stay, an expected average of 2 weeks
Evidence of clinically definite postoperative impaired coagulationParticipants 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 dialysisParticipants will be followed for the duration of hospital stay, an expected average of 2 weeks
Need for reoperation due to bleeding or cardiac causeParticipants will be followed for the duration of hospital stay, an expected average of 2 weeks
Evidence of clinically definite postoperative pulmonary or systemic congestionParticipants will be followed for the duration of hospital stay, an expected average of 2 weeks

Countries

Hungary

Contacts

Primary ContactAndrea Székely, MD, PhD
andi_szekely@yahoo.com+36206632243
Backup ContactEnikő Holndonner-Kirst, MD
kirst.eniko@gmail.com+36305058050

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026