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
Information provided by (Responsible Party):
Joon Bum Kim, Asan Medical Center
First received: June 10, 2012
Last updated: June 14, 2012
Last verified: June 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Hyperbilirubinemia After Major Cardiac or Thoracic Aorta Surgery: Predictors and Clinical Significance
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients undergoing elective major cardiac or thoracic aorta surgery
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).
- 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.
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
|Asan Medical Center
|Seoul, Korea, Republic of, 138-736 |
|Contact: Joon Bum Kim, MD 82-2-3010-5416 email@example.com |
Asan Medical Center
||Joon Bum Kim, MD
||Asan Medical Center
No publications provided
||Joon Bum Kim, Assistant Professor, Asan Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 10, 2012
||June 14, 2012
||Korea: Institutional Review Board
Keywords provided by Asan Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 29, 2014