Hyperbilirubinemia After Cardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Joon Bum Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01617902
First received: June 10, 2012
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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.


Condition
Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hyperbilirubinemia After Major Cardiac or Thoracic Aorta Surgery: Predictors and Clinical Significance

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • All cause-death [ Time Frame: Within 30 days after surgery or during postoperative hospitalization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • gastrointestinal or hepatobiliary complications requiring intervention [ Time Frame: Within 30 days after surgery or during postoperative hospitalization ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: June 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing elective major cardiac or thoracic aorta surgery

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617902

Contacts
Contact: Joon Bum Kim, MD 82-2-3010-5416 jbkim1975@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Joon Bum Kim, MD    82-2-3010-5416    jbkim1975@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Joon Bum Kim, MD Asan Medical Center
  More Information

No publications provided

Responsible Party: Joon Bum Kim, Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01617902     History of Changes
Other Study ID Numbers: HBCS_01
Study First Received: June 10, 2012
Last Updated: June 14, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
Hyperbilirubinemia
cardiac
surgery
aorta
prognosis

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperbilirubinemia
Pathologic Processes

ClinicalTrials.gov processed this record on October 30, 2014