跳至主要内容
临床试验/NCT01617902
NCT01617902Unknown不适用

Hyperbilirubinemia After Major Cardiac or Thoracic Aorta Surgery: Predictors and Clinical Significance

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
All cause-death

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

All cause-death

时间窗: Within 30 days after surgery or during postoperative hospitalization

次要结局

  • gastrointestinal or hepatobiliary complications requiring intervention(Within 30 days after surgery or during postoperative hospitalization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joon Bum Kim

Assistant Professor

Asan Medical Center

研究点 (1)

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