Cardiac SurgeryNCT02893657
The Role and Dynamics of Liver Dysfunction in Patients Undergoing Cardiac Surgery
An observational study of Cardiac Surgery and Hepatic Impairment, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Hepatic Impairment, Heart Failure
- How many people
- 150 participants
- Where
- 1 siteHungary
- Study dates
- 1 Dec 2017to May 2023
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult cardiac surgical patients
Who may be able to join
- Patients over 18 years of age admitted for elective cardiac surgical procedures
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Heart and Vascular Center, Semmelweis University
Budapest, 1122
Andrea Szekely, MD, PhD, 0036206632243, andi_szekely@yahoo.com
About this study
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.
Read the 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.
- Conditions
- Cardiac Surgery, Hepatic Impairment, Heart Failure
- Keywords
- MELD score, hemodynamics, liver abnormalities
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite of in-hospital death of any cause
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of ICU stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes (6)
Evidence of clinically definite postoperative decline in hepatic function
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Need for reoperation due to bleeding or cardiac cause
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Evidence of clinically definite postoperative pulmonary or systemic congestion
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Evidence of clinically definite postoperative low cardiac output syndrome
Measured: Participants 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 dialysis
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Evidence of clinically definite postoperative impaired coagulation
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start1 Dec 2017
- Primary completionMay 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Collaborators
- Semmelweis University
- Responsible party
- Principal investigator, Andrea Szekely, Semmelweis University
- Investigators
- Enikő Holndonner-Kirst, MD, Principal investigator, Semmelweis UniversityAndrea Székely, MD, PhD, Study director, Semmelweis UniversityDaniel Lex, MD, Principal investigator, Semmelweis UniversityNikoletta Ráhel Czobor, MD, Principal investigator, Semmelweis UniversityÁdám Nagy, MD, Principal investigator, Semmelweis UniversityJános Gál, MD, PhD, Study chair, Semmelweis UniversityBéla Merkely, MD, PhD, Study chair, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893657
- Sponsor's protocol ID
- SE AITK VSZÉK LIVER
- Status last verified
- Jan 2022
- First submitted
- 30 Aug 2016
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role and Dynamics of Liver Dysfunction in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02893657
- Acronym / sponsor ID
- SE AITK VSZÉK LIVER
- Conditions
- Cardiac Surgery, Hepatic Impairment, Heart Failure
- Keywords
- MELD score, hemodynamics, liver abnormalities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Collaborators
- Semmelweis University
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cardiac surgical patients
Key inclusion criteria (1 listed)
- Patients over 18 years of age admitted for elective cardiac surgical procedures
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Length of hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of ICU stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
6 secondary outcomes
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enikő Holndonner-Kirst, MD principal investigator
Semmelweis University
Andrea Székely, MD, PhD study director
Semmelweis University
Daniel Lex, MD principal investigator
Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and Hepatic Impairment, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Székely, MD, PhD (+36206632243, andi_szekely@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.