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NCT Number: NCT04271098

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

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.

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Key information

Conditions

Hyperbilirubinemia Cardiac Disease Cardiovascular Diseases Heart Diseases Hepatic Impairment Pathologic Processes Pathological Conditions, Signs and Symptoms Surgery

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open-Heart Surgery for nine months duration

Procedure

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

Relation between possible risk factors and hyperbilirubinemia

Other

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.

Follow-up period

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

Secondary outcomes

  1. Use of aortic cross-clamp time; as a risk factor

    Time frame: During intraoperative time

    Use of aortic cross-clamp time

  2. Use of cardiopulmonary bypass time; as a risk factor

    Time frame: During intraoperative time

    Use of cardiopulmonary bypass time

  3. 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

  4. 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

  5. Use of prolonged mechanical ventilation; as a risk factor

    Time frame: During the first 30 days of postoperative period

    Duration of prolonged mechanical ventilation

  6. Development of pneumonia; as a risk factor

    Time frame: During the first 10 days of postoperative period

    Presence of development of pneumonia

  7. 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

  8. Cerebrovascular event; a risk factor

    Time frame: During the first 10 days of postoperative period

    Development of cerebrovascular event (stroke, transient ischemic attack), seizure

  9. 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

  10. Need of renal replacement therapy; a risk factor

    Time frame: During the first 10 days of postoperative period

    Need for renal replacement therapy (RRT)

  11. Need of reoperation; a risk factor

    Time frame: During the first 10 days of postoperative period

    Need of reoperation secondary to bleeding

  12. 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

  13. 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

  14. Duration of in-hospital stay; a risk factor

    Time frame: During the first 30 days of postoperative period

    Duration of in-hospital stay

Sponsors and collaborators

Lead sponsor

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Other Gov

Registry information

Official study title

Risk Factors, Hepatic Dysfunction, and Open-heart Surgery

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 17, 2020
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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