Hyperbilirubinemia After Cardiac Surgery

June 14, 2012 updated by: Joon Bum Kim, Asan Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Cardiovascular Diseases

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- - Seoul, Korea, Republic of, 138-736
    - Recruiting
    - Asan Medical Center
    - Contact:
      
      Joon Bum Kim, MD
      
      Phone Number: 82-2-3010-5416
      
      Email: jbkim1975@amc.seoul.kr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective major cardiac or thoracic aorta surgery

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All cause-death Time Frame: Within 30 days after surgery or during postoperative hospitalization	Within 30 days after surgery or during postoperative hospitalization

Secondary Outcome Measures

Outcome Measure	Time Frame
gastrointestinal or hepatobiliary complications requiring intervention Time Frame: Within 30 days after surgery or during postoperative hospitalization	Within 30 days after surgery or during postoperative hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

Principal Investigator: Joon Bum Kim, MD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

June 10, 2012

First Submitted That Met QC Criteria