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Hyperbilirubinemia After Cardiac Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Joon Bum Kim, Asan Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01617902
First Posted: June 13, 2012
Last Update Posted: June 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joon Bum Kim, Asan Medical Center
  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 Joon Bum Kim, Asan Medical Center:

Primary Outcome Measures:
  • All cause-death [ Time Frame: Within 30 days after surgery or during postoperative hospitalization ]

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

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

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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
Information from the National Library of Medicine

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

Responsible Party: Joon Bum Kim, Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01617902     History of Changes
Other Study ID Numbers: HBCS_01
First Submitted: June 10, 2012
First Posted: June 13, 2012
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