The Investigation of the Causes of Hepatic Dysfunction in the Postoperative Period During Open-heart Surgeries

February 18, 2020 updated by: Ayse Baysal, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Risk Factors, Hepatic Dysfunction, and Open-heart Surgery

In a prospective observational study during the six-month duration, coronary artery bypass graft surgery (CABG) and valve repair surgery (mitral, mitral, and aortic valve and/or tricuspid valve) patients were investigated for hepatic dysfunction. All patients were divided into two groups as with or without hyperbilirubinemia, and this was defined by the occurrence of a plasma total bilirubin concentration of more than 34 µmol/L (2 mg/dL) in any measurement during the postoperative period. Our goal was to determine the risk factors associated with hepatic dysfunction in patients undergoing open-heart surgery with cardiopulmonary bypass. The collected parameters include; alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), total bilirubin (TBIL), and gamma-glutamyl transpeptidase (GGT) and albumin preoperatively and on postoperative days 1, 3 and 7. Possible preoperative, intraoperative, and postoperative risk factors were investigated. Logistic regression analysis was done to identify the risk factors for postoperative hyperbilirubinemia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There are a series of pathophysiological changes in patients undergoing open-heart surgeries with cardiopulmonary bypass (CPB) that causes liver hypoperfusion, centrilobular sinusoid ischemia, and subsequent reperfusion injuries, hemolysis, or systemic inflammatory response. These events may eventually lead to various forms of hepatic dysfunction in patients during the postoperative period after open-heart surgeries. An increased incidence of liver function test abnormalities were reported, and the rates vary between 10 % and 40%. The occurrence of postoperative hyperbilirubinemia is crucial in increased morbidity and mortality after open-heart surgery with CPB. There are several reports of the possible risk factors that are associated with hepatic dysfunction. In previous studies, the incidence of postoperative hyperbilirubinemia was between the range of 20% up to 51% in open-heart surgeries with CPB. The causes of this higher incidence were related to the presence of various possible risk factors, and these include; valvular heart disease and related low cardiac output states, and low ejection fraction. Other important risk factors for postoperative hepatic dysfunction after open-heart surgery with CPB were longer operative time and a larger volume of blood transfusion. However, CPB itself is not a significant constituent in the postoperative development of hyperbilirubinemia. Splanchnic ischemia before or during operation and in the postoperative period appears to be an essential cause. Other risk factors that were identified as possible risk factors for postoperative hepatic dysfunction. We can list these factors as; poor preoperative heart function, hemodynamic instability, emergency surgery, and preoperative liver dysfunction. Our goal was to determine the possible risk factors associated with hepatic dysfunction in patients undergoing open-heart surgery with CPB.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
340

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study is performed on a patient population undergoing open-heart surgery with cardiopulmonary bypass.

Description

Inclusion Criteria:

  • Patients undergoing open-heart surgery with CPB,
  • Patients between the ages of 19 to 80,
  • American Society of Anesthesiologist (ASA) status of 2 and 3,
  • Preoperative ejection fraction (EF) greater than 30%.
  • There were five different open-heart surgery group of patients in this study. The groups include; coronary artery bypass grafting (CABG), mitral valvular replacement, aortic valvular replacement, combined mitral and aortic valve replacement, combined mitral, aortic and/or tricuspid valve replacements.

Exclusion Criteria:

  • Both CABG and valve replacement,
  • Resection of a ventricular or aortic aneurysm,
  • Transplantation or another surgical procedure,
  • Reoperation of valvular repair surgery, patients with preoperative ejection fraction less than 30%,
  • Preoperative hyperbilirubinemia defined as total bilirubin concentration of more than 3 mg/dL,
  • Preoperative congestive heart failure, preoperative renal dysfunction (serum creatinine greater than 1.3 mg/dL),
  • Chronic oliguria/anuria requiring dialysis,
  • Preoperative American Society of Anesthesiologist (ASA) status of 4,
  • History of pancreatitis or current corticosteroid treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Open-heart surgery
Patients undergoing open-heart surgery with cardiopulmonary bypass
Procedure: Open-Heart Surgery for nine months duration
In a single group of patients including 340 patients undergoing open-heart surgery during a period of nine months, the collected parameters include; alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), total bilirubin (TBIL), and gamma-glutamyl transpeptidase (GGT) and albumin preoperatively and on postoperative days of 1, 3 and 7. All patients were divided into two groups as with or without hyperbilirubinemia, and this was defined by the occurrence of a plasma total bilirubin concentration of more than 34 µmol/L (2 mg/dL) in any measurement during the postoperative period. For each diagnostic test, a comparison within the group for different time points was statistically evaluated by analysis of variance tests.
Other Names:
  • Type of open-heart surgical operation (coronary artery bypass graft operation, mitral valve, aortic valve or multiple valvular surgeries)
  • Hyperbilirubinemia
  • Hepatic function related tests
Other: Relation between possible risk factors and hyperbilirubinemia
Possible preoperative, intraoperative, and postoperative risk factors were investigated. The relations between hyperbilirubinemia and possible risk factors are sought by the use of the statistical analysis methods including logistic regression analysis.
Other: Follow-up period
All patients were investigated for a period of ten days postoperatively. During this period, intensive care unit (ICU) stay, in-hospital stay, and all adverse events were recorded.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of serum total bilirubin values on postoperative day 1.
Time Frame: Preoperative one day before surgery and postoperative day 1.
Change from baseline (preoperative) of serum total bilirubin on postoperative day 1.
Preoperative one day before surgery and postoperative day 1.
Comparison of serum total bilirubin values on postoperative day 3.
Time Frame: Preoperative one day before surgery and postoperative day 3.
Change from baseline (preoperative) of serum total bilirubin on postoperative day 3.
Preoperative one day before surgery and postoperative day 3.
Comparison of serum total bilirubin values on postoperative day 7.
Time Frame: Preoperative one day before surgery and postoperative day 7.
Change from baseline (preoperative) of serum total bilirubin on postoperative day 7.
Preoperative one day before surgery and postoperative day 7.
Comparison of all serum total bilirubin values at all collected times.
Time Frame: Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
A repeated measures statistical analysis using analysis of variance tests was performed.
Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
Comparison of serum albumin values on postoperative day 1.
Time Frame: Preoperative one day before surgery and postoperative day 1.
Change from baseline (preoperative) of serum albumin on postoperative day 1.
Preoperative one day before surgery and postoperative day 1.
Comparison of serum albumin values on postoperative day 3.
Time Frame: Preoperative one day before surgery and postoperative day 3.
Change from baseline (preoperative) of serum albumin on postoperative day 3.
Preoperative one day before surgery and postoperative day 3.
Comparison of serum albumin values on postoperative day 7.
Time Frame: Preoperative one day before surgery and postoperative day 7.
Change from baseline (preoperative) of serum albumin on postoperative day 7.
Preoperative one day before surgery and postoperative day 7.
Comparison of all serum albumin values at all collected times.
Time Frame: Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
A repeated measures statistical analysis using analysis of variance tests was performed.
Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
Comparison of serum alkaline phosphatase (ALP) values on postoperative day 1.
Time Frame: Preoperative one day before surgery and on postoperative day of 1.
Change from baseline (preoperative) of serum alkaline phosphatase (ALP) on postoperative day 1.
Preoperative one day before surgery and on postoperative day of 1.
Comparison of serum alkaline phosphatase (ALP) values on postoperative day 3.
Time Frame: Preoperative one day before surgery and on postoperative day of 3.
Change from baseline (preoperative) of serum alkaline phosphatase (ALP) on postoperative day 3.
Preoperative one day before surgery and on postoperative day of 3.
Comparison of serum alkaline phosphatase (ALP) values on postoperative day 7.
Time Frame: Preoperative one day before surgery and on postoperative day of 7.
Change from baseline (preoperative) of serum alkaline phosphatase (ALP) on postoperative day 7.
Preoperative one day before surgery and on postoperative day of 7.
Comparison of all serum alkaline phosphatase (ALP) values at all collected times.
Time Frame: Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
A repeated measures statistical analysis using analysis of variance tests was performed.
Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
Comparison of serum alanine transaminase (ALT) values on postoperative day 1.
Time Frame: Preoperatively one day before surgery and on postoperative day of 1.
Change from baseline (preoperative) of serum alanine transaminase (ALT) on postoperative day 1.
Preoperatively one day before surgery and on postoperative day of 1.
Comparison of serum alanine transaminase (ALT) values on postoperative day 3.
Time Frame: Preoperatively one day before surgery and on postoperative day of 3.
Change from baseline (preoperative) of serum alanine transaminase (ALT) on postoperative day 3.
Preoperatively one day before surgery and on postoperative day of 3.
Comparison of serum alanine transaminase (ALT) values on postoperative day 7.
Time Frame: Preoperatively one day before surgery and on postoperative day of 7.
Change from baseline (preoperative) of serum alanine transaminase (ALT) on postoperative day 7.
Preoperatively one day before surgery and on postoperative day of 7.
Comparison of all serum alanine transaminase (ALT) values at all collected times.
Time Frame: Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
A repeated measures statistical analysis using analysis of variance tests was performed.
Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
Comparison of serum aspartate transaminase (AST) values on postoperative day 1.
Time Frame: Preoperatively one day before surgery and on postoperative day of 1.
Change from baseline (preoperative) of serum aspartate transaminase (AST) on postoperative day 1.
Preoperatively one day before surgery and on postoperative day of 1.
Comparison of serum aspartate transaminase (AST) values on postoperative day 3.
Time Frame: Preoperatively one day before surgery and on postoperative day of 3.
Serum aspartate transaminase (AST) values were collected preoperative and postoperative day 3.
Preoperatively one day before surgery and on postoperative day of 3.
Comparison of serum aspartate transaminase (AST)values on postoperative day 7.
Time Frame: Preoperatively one day before surgery and on postoperative day of 7.
Serum aspartate transaminase (AST) values were collected preoperative and postoperative day 7.
Preoperatively one day before surgery and on postoperative day of 7.
Comparison of all serum aspartate transaminase (AST) values at all collected times.
Time Frame: Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
A repeated measures statistical analysis using analysis of variance tests was performed.
Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
Comparison of serum lactate dehydrogenase (LDH) values on postoperative day 1.
Time Frame: Preoperatively one day before surgery and on postoperative day of 1.
Change from baseline (preoperative) of serum lactate dehydrogenase (LDH) on postoperative day 1.
Preoperatively one day before surgery and on postoperative day of 1.
Comparison of serum lactate dehydrogenase (LDH) values on postoperative day 3.
Time Frame: Preoperatively one day before surgery and on postoperative day of 3.
Change from baseline (preoperative) of serum lactate dehydrogenase (LDH) on postoperative day 3.
Preoperatively one day before surgery and on postoperative day of 3.
Comparison of serum lactate dehydrogenase (LDH) values on postoperative day 7.
Time Frame: Preoperatively one day before surgery and on postoperative day of 7.
Change from baseline (preoperative) of serum lactate dehydrogenase (LDH) on postoperative day 7.
Preoperatively one day before surgery and on postoperative day of 7.
Comparison of all serum lactate dehydrogenase (LDH) values at collected times.
Time Frame: Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
A repeated measures statistical analysis using analysis of variance tests was performed.
Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
Comparison of serum glutamyl transpeptidase (GGT) values on postoperative day 1.
Time Frame: Preoperatively one day before surgery and on postoperative day of 1.
Change from baseline (preoperative) of serum glutamyl transpeptidase (GGT) on postoperative day 1.
Preoperatively one day before surgery and on postoperative day of 1.
Comparison of serum glutamyl transpeptidase (GGT) values on postoperative day 3.
Time Frame: Preoperatively one day before surgery and on postoperative day of 3.
Change from baseline (preoperative) of serum glutamyl transpeptidase (GGT) on postoperative day 3.
Preoperatively one day before surgery and on postoperative day of 3.
Comparison of serum glutamyl transpeptidase (GGT) values on postoperative day 7.
Time Frame: Preoperatively one day before surgery and on postoperative day of 7.
Change from baseline (preoperative) of serum glutamyl transpeptidase (GGT) on postoperative day 7.
Preoperatively one day before surgery and on postoperative day of 7.
Comparison of all serum glutamyl transpeptidase (GGT) values at collected times.
Time Frame: Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
A repeated measures statistical analysis using analysis of variance tests was performed.
Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Use of aortic cross-clamp time; as a risk factor
Time Frame: During intraoperative time
Use of aortic cross-clamp time
During intraoperative time
Use of cardiopulmonary bypass time; as a risk factor
Time Frame: During intraoperative time
Use of cardiopulmonary bypass time
During intraoperative time
Use of inotropic support; as a risk factor
Time Frame: During intraoperative time and in the first 10 days of postoperative period
Use of various inotropic support agents
During intraoperative time and in the first 10 days of postoperative period
Use of intra-aortic balloon pump; as a risk factor
Time Frame: During intraoperative time and in the first 10 days of postoperative period
Use of intra-aortic balloon pump
During intraoperative time and in the first 10 days of postoperative period
Use of prolonged mechanical ventilation; as a risk factor
Time Frame: During the first 30 days of postoperative period
Duration of prolonged mechanical ventilation
During the first 30 days of postoperative period
Development of pneumonia; as a risk factor
Time Frame: During the first 10 days of postoperative period
Presence of development of pneumonia
During the first 10 days of postoperative period
Development of perioperative heart attack; a rsik factor
Time Frame: During intraoperative time and in the first 10 days of postoperative period
Presence of perioperative myocardial infarction
During intraoperative time and in the first 10 days of postoperative period
Cerebrovascular event; a risk factor
Time Frame: During the first 10 days of postoperative period
Development of cerebrovascular event (stroke, transient ischemic attack), seizure
During the first 10 days of postoperative period
Presence of rhythm disturbance; a risk factor
Time Frame: During intraoperative time and in the first 10 days of postoperative period
Presence of atrial fibrillation and other rhythm disturbances
During intraoperative time and in the first 10 days of postoperative period
Need of renal replacement therapy; a risk factor
Time Frame: During the first 10 days of postoperative period
Need for renal replacement therapy (RRT)
During the first 10 days of postoperative period
Need of reoperation; a risk factor
Time Frame: During the first 10 days of postoperative period
Need of reoperation secondary to bleeding
During the first 10 days of postoperative period
Presence of other adverse events; a risk factor
Time Frame: During the first 10 days of postoperative period
Presence of other adverse events such as; development of sepsis or need for tracheostomy
During the first 10 days of postoperative period
Duration of intensive care unit stay; a risk factor
Time Frame: During the first 10 days of postoperative period
Duration of intensive care unit stay
During the first 10 days of postoperative period
Duration of in-hospital stay; a risk factor
Time Frame: During the first 30 days of postoperative period
Duration of in-hospital stay
During the first 30 days of postoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011.3/05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We can share the study protocol, clinical study report, the excel data of our clinical work.

IPD Sharing Time Frame

The data is available upon registration and it will be available on the web site if needed.

IPD Sharing Access Criteria

Accessible to all researchers.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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