Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hyperbilirubinemia After Cardiac Surgery

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.
 
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

Tracking Information
First Submitted Date June 10, 2012
First Posted Date June 13, 2012
Last Update Posted Date June 18, 2012
Study Start Date June 2012
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2012)
All cause-death [ Time Frame: Within 30 days after surgery or during postoperative hospitalization ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01617902 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 10, 2012)
gastrointestinal or hepatobiliary complications requiring intervention [ Time Frame: Within 30 days after surgery or during postoperative hospitalization ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hyperbilirubinemia After Cardiac Surgery
Official Title Hyperbilirubinemia After Major Cardiac or Thoracic Aorta Surgery: Predictors and Clinical Significance
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing elective major cardiac or thoracic aorta surgery
Condition Cardiovascular Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 10, 2012)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2013
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01617902
Other Study ID Numbers HBCS_01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Joon Bum Kim, Asan Medical Center
Study Sponsor Asan Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Joon Bum Kim, MD Asan Medical Center
PRS Account Asan Medical Center
Verification Date June 2012