HyperbilirubinemiaNCT04271098

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

An observational study of Hyperbilirubinemia and Hepatic Impairment, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 19 to 80 years
Conditions the study is for: Hyperbilirubinemia, Hepatic Impairment, Surgery
What is being tested?: Open-Heart Surgery for nine months duration, Relation between possible risk factors and hyperbilirubinemia and Follow-up period
Type of treatment: Surgery or procedure
How many people: 340 participants
Where: No sites listed yet
Study dates: 1 Jan 2012to 1 Sep 2012
How long will I take part?: 10 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 19 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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),

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Chronic oliguria/anuria requiring dialysis,
Preoperative American Society of Anesthesiologist (ASA) status of 4,
History of pancreatitis or current corticosteroid treatment.

About this study

Official title: 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.

Read the 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.

Conditions: Hyperbilirubinemia, Hepatic Impairment, Surgery, Cardiac Disease
Being tested: Open-Heart Surgery for nine months duration, Relation between possible risk factors and hyperbilirubinemia, Follow-up period
Keywords: open-heart surgery, postoperative, complications, hyperbilirubinemia, hepatic impairment
Medical subject headings: Hyperbilirubinemia, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Open-Heart Surgery for nine months durationProcedure or surgery
Also called Type of open-heart surgical operation (coronary artery bypass graft operation, mitral valve, aortic valve or multiple valvular surgeries), Hyperbilirubinemia, Hepatic function related tests
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.
Relation between possible risk factors and hyperbilirubinemiaOther
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 periodOther
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.

Study groups in NCT04271098
Study group	Role	What they receive
Open-heart surgery		Patients undergoing open-heart surgery with cardiopulmonary bypass Receives: Procedure: Open-Heart Surgery for nine months duration; Other: Relation between possible risk factors and hyperbilirubinemia; Other: Follow-up period

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of serum total bilirubin values on postoperative day 1.
Change from baseline (preoperative) of serum total bilirubin on postoperative day 1.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Use of aortic cross-clamp time
Measured: During intraoperative time
Use of cardiopulmonary bypass time; as a risk factor
Use of cardiopulmonary bypass time
Measured: During intraoperative time
Use of inotropic support; as a risk factor
Use of various inotropic support agents
Measured: During intraoperative time and in the first 10 days of postoperative period
Use of intra-aortic balloon pump; as a risk factor
Use of intra-aortic balloon pump
Measured: During intraoperative time and in the first 10 days of postoperative period
Use of prolonged mechanical ventilation; as a risk factor
Duration of prolonged mechanical ventilation
Measured: During the first 30 days of postoperative period
Development of pneumonia; as a risk factor
Presence of development of pneumonia
Measured: During the first 10 days of postoperative period
Development of perioperative heart attack; a rsik factor
Presence of perioperative myocardial infarction
Measured: During intraoperative time and in the first 10 days of postoperative period
Cerebrovascular event; a risk factor
Development of cerebrovascular event (stroke, transient ischemic attack), seizure
Measured: During the first 10 days of postoperative period
Presence of rhythm disturbance; a risk factor
Presence of atrial fibrillation and other rhythm disturbances
Measured: During intraoperative time and in the first 10 days of postoperative period
Need of renal replacement therapy; a risk factor
Need for renal replacement therapy (RRT)
Measured: During the first 10 days of postoperative period
Need of reoperation; a risk factor
Need of reoperation secondary to bleeding
Measured: During the first 10 days of postoperative period
Presence of other adverse events; a risk factor
Presence of other adverse events such as; development of sepsis or need for tracheostomy
Measured: During the first 10 days of postoperative period
Duration of intensive care unit stay; a risk factor
Duration of intensive care unit stay
Measured: During the first 10 days of postoperative period
Duration of in-hospital stay; a risk factor
Duration of in-hospital stay
Measured: During the first 30 days of postoperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20121 Sep 2012

First posted17 Feb 2020
Study start1 Jan 2012
Primary completion1 Jul 2012
Study completion1 Sep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for HyperbilirubinemiaStudies 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: 340 participants (actual)
Target duration: 10 Days

IDs, dates and publications

ClinicalTrials.gov ID: NCT04271098
Sponsor's protocol ID: 2011.3/05
Status last verified: Feb 2020
First submitted: 11 Feb 2020
Last updated: 20 Feb 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We can share the study protocol, clinical study report, the excel data of our clinical work.

Publications

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.
PubMed 31559024
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.
PubMed 8078336
Michalopoulos A, Alivizatos P, Geroulanos S. Hepatic dysfunction following cardiac surgery: determinants and consequences. Hepatogastroenterology. 1997 May-Jun;44(15):779-83.
PubMed 9222689
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.
PubMed 6033384
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.
PubMed 6133152
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.
PubMed 6695353
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.
PubMed 10874271
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.
PubMed 15155313
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.
PubMed 14677737
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.
PubMed 18304122
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.
PubMed 26405017

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
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All Hyperbilirubinemia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Risk Factors, Hepatic Dysfunction, and Open-heart Surgery
ClinicalTrials.gov ID: NCT04271098
Acronym / sponsor ID: 2011.3/05
Conditions: Hyperbilirubinemia, Hepatic Impairment, Surgery, Cardiac Disease
Keywords: open-heart surgery, postoperative, complications, hyperbilirubinemia, hepatic impairment
Study type: Observational
Recruitment status: Completed
Enrolment: 340 participants (actual)
Lead sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitalOther government
Study start: 1 Jan 2012 (actual)
Primary completion: 1 Jul 2012 (actual)
Study completion: 1 Sep 2012 (actual)
First posted: 17 Feb 2020 (actual)
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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 10 Days
Number of arms: 1

Arm	Type	Receives
Open-heart surgery	–	Procedure: Open-Heart Surgery for nine months duration, Other: Relation between possible risk factors and hyperbilirubinemia, Other: Follow-up periodPatients undergoing open-heart surgery with cardiopulmonary bypass

Who may qualify

Ages: 19 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study is performed on a patient population undergoing open-heart surgery with cardiopulmonary bypass.

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Open-Heart Surgery for nine months durationAlso: Type of open-heart surgical operation (coronary artery bypass graft operation, mitral valve, aortic valve or multiple valvular surgeries), Hyperbilirubinemia, Hepatic function related testsIn 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.	Procedure or surgery	Open-heart surgery
Relation between possible risk factors and hyperbilirubinemiaPossible 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	Open-heart surgery
Follow-up periodAll 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.	Other	Open-heart surgery

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

14 secondary outcomes

Use of aortic cross-clamp time; as a risk factor
Time frame: During intraoperative time
Use of cardiopulmonary bypass time; as a risk factor
Time frame: 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 intra-aortic balloon pump; as a risk factor
Time frame: 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
Development of pneumonia; as a risk factor
Time frame: 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
Cerebrovascular event; a risk factor
Time frame: 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
Need of renal replacement therapy; a risk factor
Time frame: During the first 10 days of postoperative period
Need of reoperation; a risk factor
Time frame: 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
Duration of intensive care unit stay; a risk factor
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
Background: PubMed 31559024Zhou 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.
Results publication: PubMed 8078336Wang 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.
Results publication: PubMed 9222689Michalopoulos A, Alivizatos P, Geroulanos S. Hepatic dysfunction following cardiac surgery: determinants and consequences. Hepatogastroenterology. 1997 May-Jun;44(15):779-83.
Results publication: PubMed 6033384Lockey 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.
Results publication: PubMed 6133152Collins 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.
Results publication: PubMed 6695353Chu 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.
Results publication: PubMed 10874271Naschitz 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.
Results publication: PubMed 15155313McSweeney 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.
Results publication: PubMed 14677737D'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.
Results publication: PubMed 18304122Atoui 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.
Results publication: PubMed 26405017Sharma 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.
Individual participant dataSharing planned: Yes. We can share the study protocol, clinical study report, the excel data of our clinical work.

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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.

Ayse Baysal, MD principal investigator

Pendik Bolge Hospital

Questions about this trial

What is this clinical trial studying?

An observational study of Hyperbilirubinemia and Hepatic Impairment, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital.

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 5 inclusion and 9 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: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of serum total bilirubin values on postoperative day 1. (time frame: Preoperative one day before surgery and postoperative day 1.). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04271098, which also lists 11 linked publications.

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 20 Feb 2020.