CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 340 enrolled
Drug / intervention
Open-Heart Surgery for nine months duration +2 moreprocedure
Likely dose
Not stated in record
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Search/NCT04271098
NCT04271098N/ACompleted

Risk Factors, Hepatic Dysfunction, and Open-heart Surgery

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital·observational·Posted Feb 17, 2020·Updated Feb 20, 2020

In Brief

An observational study evaluating Open-Heart Surgery for nine months duration, Relation between possible risk factors and hyperbilirubinemia, and 1 other intervention for Hyperbilirubinemia and 3 related conditions. Completed, enrolled 340 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 17, 2020
Enrollment StartJan 1, 2012
Primary CompletionJul 1, 2012
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.4 years ago

Interventions

Open-Heart Surgery for nine months durationprocedure

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.