Hyperbilirubinemia After Cardiac Surgery

Cardiovascular Diseases Clinical Trial

Official title:

Hyperbilirubinemia After Major Cardiac or Thoracic Aorta Surgery: Predictors and Clinical Significance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01617902
• Other study ID #: HBCS_01
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2012
• Last updated: June 14, 2012
• Start date: June 2012
• Est. completion date: August 2013

Study information

• Verified date: June 2012
• Source: Asan Medical Center
• Contact: Joon Bum Kim, MD
• Phone: 82-2-3010-5416
• Email: jbkim1975[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hyperbilirubinemia

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause-death		Within 30 days after surgery or during postoperative hospitalization	No
Secondary	gastrointestinal or hepatobiliary complications requiring intervention		Within 30 days after surgery or during postoperative hospitalization	No