Hyperbilirubinemia After Cardiac Surgery

• Conditions: Cardiovascular Diseases

• Registration Number: NCT01617902
• Lead Sponsor: Asan Medical Center

Brief Summary

This study aims to evaluate the incidence and risk factors of hyperbilirubinemia following major cardiac or thoracic aorta surgery, and to determine the clinical impacts of the hyperbilirubinemia on postoperative mortality and morbidity.

Detailed Description

Patients receiving elective cardiac or thoracic aorta surgery will be monitored for the development of postoperative hyperbilirubinemia. Collection of data will include patient baseline demographic characteristics, laboratory and echocardiographic findings, procedural factors of the surgery, and early postoperative variables. Serial postoperative liver function testings will be done during the hospitalization. Postoperative hyperbilirubinemia is defined as serum bilirubin level of 3mg/dL.

Study Timeline

• Status Verified: 2012-06
• Study Start: 2012-06
• Study First Submitted: 2012-06-10
• Study First Submitted QC: 2012-06-10
• Study First Posted: 2012-06-13
• Last Update Submitted: 2012-06-14
• Last Update Posted: 2012-06-18
• Primary Completion: 2013-06
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Patients aged over 18 years who are scheduled to undergo elective major cardiac or thoracic aorta surgery. Major cardiac surgery includes coronary artery bypass grafting, pericardiectomy and corrections of cardiac diseases using cardiopulmonary bypassing (valve surgery, tumor excision, arrhythmia surgery, heart transplantation, ventricular reconstruction, pulmonary thromboembolectomy, and atrial or ventricular septal defects closure).

Exclusion Criteria

1. univentricular or one-and-half ventricle repairs
2. presence of known liver cirrhosis or hepatic cancer
3. history of liver transplantation
4. Genetic diseases that affects bilirubin metabolism (i.e. Gilbert syndrome)
5. preoperative bilirubin level of 3mg/dL or more.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause-death	Within 30 days after surgery or during postoperative hospitalization

Secondary Outcome Measures

Name	Time	Method
gastrointestinal or hepatobiliary complications requiring intervention	Within 30 days after surgery or during postoperative hospitalization

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of