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

NCT04271098 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 340

Last updated 2020-02-20

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • Ayse Baysal, MD · Pendik Bolge Hospital

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-01
Primary Completion
2012-07-01
Completion
2012-09-01

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Read the full study record

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View NCT04271098 on ClinicalTrials.gov