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

NCT ID: NCT02893657

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2023-05-31

Brief Summary

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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

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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.

Conditions

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Cardiac Surgery Hepatic Impairment Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Semmelweis University

OTHER

Sponsor Role collaborator

Semmelweis University Heart and Vascular Center

OTHER

Sponsor Role lead

Responsible Party

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Andrea Szekely

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enikő Holndonner-Kirst, MD

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Andrea Székely, MD, PhD

Role: STUDY_DIRECTOR

Semmelweis University

Daniel Lex, MD

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Nikoletta Ráhel Czobor, MD

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Ádám Nagy, MD

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

János Gál, MD, PhD

Role: STUDY_CHAIR

Semmelweis University

Béla Merkely, MD, PhD

Role: STUDY_CHAIR

Semmelweis University

Locations

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Heart and Vascular Center, Semmelweis University

Budapest, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Andrea Székely, MD, PhD

Role: CONTACT

+36206632243

Enikő Holndonner-Kirst, MD

Role: CONTACT

+36305058050

Facility Contacts

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Andrea Szekely, MD, PhD

Role: primary

0036206632243

Other Identifiers

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SE AITK VSZÉK LIVER

Identifier Type: -

Identifier Source: org_study_id

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