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

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ClinicalTrials.gov Identifier: NCT02893657
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
Semmelweis University
Information provided by (Responsible Party):
Andrea Szekely, Semmelweis University

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.

Condition or disease
Cardiac Surgery Hepatic Impairment Heart Failure

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Days
Official Title: The Role and Dynamics of Liver Dysfunction in Patients Undergoing Cardiac Surgery
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery




Primary Outcome Measures :
  1. The composite of in-hospital death of any cause [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
  2. Length of hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
  3. Length of ICU stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]

Secondary Outcome Measures :
  1. Evidence of clinically definite postoperative decline in hepatic function [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
  2. Need for reoperation due to bleeding or cardiac cause [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
  3. Evidence of clinically definite postoperative pulmonary or systemic congestion [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
  4. Evidence of clinically definite postoperative low cardiac output syndrome [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
  5. Evidence of clinically definite postoperative acute kidney injury and the need for dialysis [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
  6. Evidence of clinically definite postoperative impaired coagulation [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult cardiac surgical patients
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893657


Contacts
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Contact: Andrea Székely, MD, PhD +36206632243 andi_szekely@yahoo.com
Contact: Enikő Holndonner-Kirst, MD +36305058050 kirst.eniko@gmail.com

Locations
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Hungary
Heart and Vascular Center, Semmelweis University Recruiting
Budapest, Hungary, 1122
Contact: Andrea Szekely, MD, PhD    0036206632243    andi_szekely@yahoo.com   
Sponsors and Collaborators
Semmelweis University Heart and Vascular Center
Semmelweis University
Investigators
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Principal Investigator: Enikő Holndonner-Kirst, MD Semmelweis University
Study Director: Andrea Székely, MD, PhD Semmelweis University
Principal Investigator: Daniel Lex, MD Semmelweis University
Principal Investigator: Nikoletta Ráhel Czobor, MD Semmelweis University
Principal Investigator: Ádám Nagy, MD Semmelweis University
Study Chair: János Gál, MD, PhD Semmelweis University
Study Chair: Béla Merkely, MD, PhD Semmelweis University

Additional Information:

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Responsible Party: Andrea Szekely, associate professor, Semmelweis University
ClinicalTrials.gov Identifier: NCT02893657     History of Changes
Other Study ID Numbers: SE AITK VSZÉK LIVER
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Andrea Szekely, Semmelweis University:
MELD score
hemodynamics
liver abnormalities
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases