Clinical trial NCT04271098: The Investigation of the Causes of Hepatic Dysfunction in the Postoperative Period During Open-heart Surgeries
Official title: Risk Factors, Hepatic Dysfunction, and Open-heart Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperbilirubinemia
Hepatic Impairment
Surgery
Cardiac Disease
Keywords: open-heart surgery
postoperative
complications
hyperbilirubinemia
hepatic impairment
Lead sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-17
Enrollment: 340
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study is performed on a patient population undergoing open-heart surgery with cardiopulmonary bypass.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of serum total bilirubin values on postoperative day 1.
timeFrame: Preoperative one day before surgery and postoperative day 1.
measure: Comparison of serum total bilirubin values on postoperative day 3.
timeFrame: Preoperative one day before surgery and postoperative day 3.
measure: Comparison of serum total bilirubin values on postoperative day 7.
timeFrame: Preoperative one day before surgery and postoperative day 7.
measure: Comparison of all serum total bilirubin values at all collected times.
timeFrame: Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
measure: Comparison of serum albumin values on postoperative day 1.
timeFrame: Preoperative one day before surgery and postoperative day 1.
measure: Comparison of serum albumin values on postoperative day 3.
timeFrame: Preoperative one day before surgery and postoperative day 3.
measure: Comparison of serum albumin values on postoperative day 7.
timeFrame: Preoperative one day before surgery and postoperative day 7.
measure: Comparison of all serum albumin values at all collected times.
timeFrame: Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
measure: Comparison of serum alkaline phosphatase (ALP) values on postoperative day 1.
timeFrame: Preoperative one day before surgery and on postoperative day of 1.
measure: Comparison of serum alkaline phosphatase (ALP) values on postoperative day 3.
timeFrame: Preoperative one day before surgery and on postoperative day of 3.
measure: Comparison of serum alkaline phosphatase (ALP) values on postoperative day 7.
timeFrame: Preoperative one day before surgery and on postoperative day of 7.
measure: Comparison of all serum alkaline phosphatase (ALP) values at all collected times.
timeFrame: Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
measure: Comparison of serum alanine transaminase (ALT) values on postoperative day 1.
timeFrame: Preoperatively one day before surgery and on postoperative day of 1.
measure: Comparison of serum alanine transaminase (ALT) values on postoperative day 3.
timeFrame: Preoperatively one day before surgery and on postoperative day of 3.
measure: Comparison of serum alanine transaminase (ALT) values on postoperative day 7.
timeFrame: Preoperatively one day before surgery and on postoperative day of 7.
measure: Comparison of all serum alanine transaminase (ALT) values at all collected times.
timeFrame: Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
measure: Comparison of serum aspartate transaminase (AST) values on postoperative day 1.
timeFrame: Preoperatively one day before surgery and on postoperative day of 1.
measure: Comparison of serum aspartate transaminase (AST) values on postoperative day 3.
timeFrame: Preoperatively one day before surgery and on postoperative day of 3.
measure: Comparison of serum aspartate transaminase (AST)values on postoperative day 7.
timeFrame: Preoperatively one day before surgery and on postoperative day of 7.
measure: Comparison of all serum aspartate transaminase (AST) values at all collected times.
timeFrame: Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
measure: Comparison of serum lactate dehydrogenase (LDH) values on postoperative day 1.
timeFrame: Preoperatively one day before surgery and on postoperative day of 1.
measure: Comparison of serum lactate dehydrogenase (LDH) values on postoperative day 3.
timeFrame: Preoperatively one day before surgery and on postoperative day of 3.
measure: Comparison of serum lactate dehydrogenase (LDH) values on postoperative day 7.
timeFrame: Preoperatively one day before surgery and on postoperative day of 7.
measure: Comparison of all serum lactate dehydrogenase (LDH) values at collected times.
timeFrame: Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
measure: Comparison of serum glutamyl transpeptidase (GGT) values on postoperative day 1.
timeFrame: Preoperatively one day before surgery and on postoperative day of 1.
measure: Comparison of serum glutamyl transpeptidase (GGT) values on postoperative day 3.
timeFrame: Preoperatively one day before surgery and on postoperative day of 3.
measure: Comparison of serum glutamyl transpeptidase (GGT) values on postoperative day 7.
timeFrame: Preoperatively one day before surgery and on postoperative day of 7.
measure: Comparison of all serum glutamyl transpeptidase (GGT) values at collected times.
timeFrame: Preoperatively one day before surgery and on postoperative days of 1, 3 and 7.
Secondary outcomes:
measure: Use of aortic cross-clamp time; as a risk factor
timeFrame: During intraoperative time
measure: Use of cardiopulmonary bypass time; as a risk factor
timeFrame: During intraoperative time
measure: Use of inotropic support; as a risk factor
timeFrame: During intraoperative time and in the first 10 days of postoperative period
measure: Use of intra-aortic balloon pump; as a risk factor
timeFrame: During intraoperative time and in the first 10 days of postoperative period
measure: Use of prolonged mechanical ventilation; as a risk factor
timeFrame: During the first 30 days of postoperative period
measure: Development of pneumonia; as a risk factor
timeFrame: During the first 10 days of postoperative period
measure: Development of perioperative heart attack; a rsik factor
timeFrame: During intraoperative time and in the first 10 days of postoperative period
measure: Cerebrovascular event; a risk factor
timeFrame: During the first 10 days of postoperative period
measure: Presence of rhythm disturbance; a risk factor
timeFrame: During intraoperative time and in the first 10 days of postoperative period
measure: Need of renal replacement therapy; a risk factor
timeFrame: During the first 10 days of postoperative period
measure: Need of reoperation; a risk factor
timeFrame: During the first 10 days of postoperative period
measure: Presence of other adverse events; a risk factor
timeFrame: During the first 10 days of postoperative period
measure: Duration of intensive care unit stay; a risk factor
timeFrame: During the first 10 days of postoperative period
measure: Duration of in-hospital stay; a risk factor
timeFrame: During the first 30 days of postoperative period
Other outcomes:
Locations:
Study officials:
affiliation: Pendik Bolge Hospital
name: Ayse Baysal, MD
role: PRINCIPAL_INVESTIGATOR
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