Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-04-26 @ 7:05 AM
Study NCT ID:
NCT02893657
Status:
UNKNOWN
Last Update Posted:
2022-01-11
First Post:
2016-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role and Dynamics of Liver Dysfunction in Patients Undergoing Cardiac Surgery
Sponsor:
Semmelweis University Heart and Vascular Center
Organization:
Study Overview
Official Title:
The Role and Dynamics of Liver Dysfunction in Patients Undergoing Cardiac Surgery
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: