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Hyperbilirubinemia After Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01617902
Recruitment Status : Unknown
Verified June 2012 by Joon Bum Kim, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : June 13, 2012
Last Update Posted : June 18, 2012
Sponsor:
Information provided by (Responsible Party):
Joon Bum Kim, Asan Medical Center

Study Description
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Brief 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.

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hyperbilirubinemia After Major Cardiac or Thoracic Aorta Surgery: Predictors and Clinical Significance
Study Start Date : June 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. All cause-death [ Time Frame: Within 30 days after surgery or during postoperative hospitalization ]

Secondary Outcome Measures :
  1. gastrointestinal or hepatobiliary complications requiring intervention [ Time Frame: Within 30 days after surgery or during postoperative hospitalization ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Joon Bum Kim, Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01617902     History of Changes
Other Study ID Numbers: HBCS_01
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: June 2012

Keywords provided by Joon Bum Kim, Asan Medical Center:
Hyperbilirubinemia
cardiac
surgery
aorta
prognosis

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperbilirubinemia
Pathologic Processes