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

NCT04271098 | Completed

• 1 other identifier: 2011.3/05
• Study Type: observational
• Target: 340
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperbilirubinemia; Hepatic Impairment; Surgery; Cardiac Disease

Keywords

open-heart surgery; postoperative; complications; hyperbilirubinemia; hepatic impairment

Outcome Measures

Primary Outcomes (28)

• Comparison of serum total bilirubin values on 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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 Outcomes (14)

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

  During intraoperative time

• Use of cardiopulmonary bypass time; as a risk factor

  During intraoperative time

• Use of inotropic support; as a risk factor

  During intraoperative time and in the first 10 days of postoperative period

• Use of intra-aortic balloon pump; as a risk factor

  During intraoperative time and in the first 10 days of postoperative period

• Use of prolonged mechanical ventilation; as a risk factor

  During the first 30 days of postoperative period

Study Arms (1)

Open-heart surgery

Patients undergoing open-heart surgery with cardiopulmonary bypass

Procedure: Open-Heart Surgery for nine months duration; Other: Relation between possible risk factors and hyperbilirubinemia; Other: Follow-up period

Interventions

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.

Also known as: Type of open-heart surgical operation (coronary artery bypass graft operation, mitral valve, aortic valve or multiple valvular surgeries), Hyperbilirubinemia, Hepatic function related tests

Open-heart surgery

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.

Open-heart surgery

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.

Open-heart surgery

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital: lead

Related Publications (11)

• Zhou W, Wang G, Liu Y, Tao Y, Du Z, Tang Y, Qiao F, Liu Y, Xu Z. Outcomes and risk factors of postoperative hepatic dysfunction in patients undergoing acute type A aortic dissection surgery. J Thorac Dis. 2019 Aug;11(8):3225-3233. doi: 10.21037/jtd.2019.08.72.

  PMID: 31559024 BACKGROUND

• Wang MJ, Chao A, Huang CH, Tsai CH, Lin FY, Wang SS, Liu CC, Chu SH. Hyperbilirubinemia after cardiac operation. Incidence, risk factors, and clinical significance. J Thorac Cardiovasc Surg. 1994 Sep;108(3):429-36.

  PMID: 8078336 RESULT

• Michalopoulos A, Alivizatos P, Geroulanos S. Hepatic dysfunction following cardiac surgery: determinants and consequences. Hepatogastroenterology. 1997 May-Jun;44(15):779-83.

  PMID: 9222689 RESULT

• Lockey E, McIntyre N, Ross DN, Brookes E, Sturridge MF. Early jaundice after open-heart surgery. Thorax. 1967 Mar;22(2):165-9. doi: 10.1136/thx.22.2.165.

  PMID: 6033384 RESULT

• Collins JD, Bassendine MF, Ferner R, Blesovsky A, Murray A, Pearson DT, James OF. Incidence and prognostic importance of jaundice after cardiopulmonary bypass surgery. Lancet. 1983 May 21;1(8334):1119-23. doi: 10.1016/s0140-6736(83)92863-5.

  PMID: 6133152 RESULT

• Chu CM, Chang CH, Liaw YF, Hsieh MJ. Jaundice after open heart surgery: a prospective study. Thorax. 1984 Jan;39(1):52-6. doi: 10.1136/thx.39.1.52.

  PMID: 6695353 RESULT

• Naschitz JE, Slobodin G, Lewis RJ, Zuckerman E, Yeshurun D. Heart diseases affecting the liver and liver diseases affecting the heart. Am Heart J. 2000 Jul;140(1):111-20. doi: 10.1067/mhj.2000.107177.

  PMID: 10874271 RESULT

• McSweeney ME, Garwood S, Levin J, Marino MR, Wang SX, Kardatzke D, Mangano DT, Wolman RL; Investigators of the Ischemia Research and Education Foundation and the Multicenter Study of Perioperative Ischemia Research Group. Adverse gastrointestinal complications after cardiopulmonary bypass: can outcome be predicted from preoperative risk factors? Anesth Analg. 2004 Jun;98(6):1610-1617. doi: 10.1213/01.ANE.0000113556.40345.2E.

  PMID: 15155313 RESULT

• D'Ancona G, Baillot R, Poirier B, Dagenais F, de Ibarra JI, Bauset R, Mathieu P, Doyle D. Determinants of gastrointestinal complications in cardiac surgery. Tex Heart Inst J. 2003;30(4):280-5.

  PMID: 14677737 RESULT

• Atoui R, Ma F, Langlois Y, Morin JF. Risk factors for prolonged stay in the intensive care unit and on the ward after cardiac surgery. J Card Surg. 2008 Mar-Apr;23(2):99-106. doi: 10.1111/j.1540-8191.2007.00564.x.

  PMID: 18304122 RESULT

• Sharma P, Ananthanarayanan C, Vaidhya N, Malhotra A, Shah K, Sharma R. Hyperbilirubinemia after cardiac surgery: An observational study. Asian Cardiovasc Thorac Ann. 2015 Nov;23(9):1039-43. doi: 10.1177/0218492315607149. Epub 2015 Sep 23.

  PMID: 26405017 RESULT

MeSH Terms

Conditions

Hyperbilirubinemia; Heart Diseases

Interventions

Time

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Ayse Baysal, MD

  Pendik Bolge Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 17, 2020
• Study Start: January 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data is available upon registration and it will be available on the web site if needed.
• Access Criteria: Accessible to all researchers.