Hyperbilirubinemia After Cardiac Surgery
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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 |
- All cause-death [ Time Frame: Within 30 days after surgery or during postoperative hospitalization ] [ Designated as safety issue: No ]
- 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) |
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 |
Patients undergoing elective major cardiac or thoracic aorta surgery
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.
Contacts and Locations| Contact: Joon Bum Kim, MD | 82-2-3010-5416 | jbkim1975@amc.seoul.kr |
| 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 | |
| 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 May 16, 2013