Clinical trial NCT02893657: The Role and Dynamics of Liver Dysfunction in Patients Undergoing Cardiac Surgery
Official title: The Role and Dynamics of Liver Dysfunction in Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Surgery
Hepatic Impairment
Heart Failure
Keywords: MELD score
hemodynamics
liver abnormalities
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
Collaborators: name: Semmelweis University
First posted: 2016-09-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult cardiac surgical patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The composite of in-hospital death of any cause
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Length of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Length of ICU stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: Evidence of clinically definite postoperative decline in hepatic function
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Need for reoperation due to bleeding or cardiac cause
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Evidence of clinically definite postoperative pulmonary or systemic congestion
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Evidence of clinically definite postoperative low cardiac output syndrome
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Evidence of clinically definite postoperative acute kidney injury and the need for dialysis
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Evidence of clinically definite postoperative impaired coagulation
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Heart and Vascular Center, Semmelweis University
Study officials:
affiliation: Semmelweis University
name: Enikő Holndonner-Kirst, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis University
name: Andrea Székely, MD, PhD
role: STUDY_DIRECTOR
affiliation: Semmelweis University
name: Daniel Lex, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis University
name: Nikoletta Ráhel Czobor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis University
name: Ádám Nagy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis University
name: János Gál, MD, PhD
role: STUDY_CHAIR
affiliation: Semmelweis University
name: Béla Merkely, MD, PhD
role: STUDY_CHAIR
References: