Postoperative Renal, Pulmonary, Cardiovascular Complications and Use of Blood Components in Patients Undergoing Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Incidence of renal complication after liver transplantation
研究概览
简要总结
Incidence and risk factors for renal, cardiovascular and pulmonary complications after liver transplantation are not well defined. Blood products requirement is an important aspect of orthotropic liver transplantation (OLTx) management and has a great impact on patient's outcome. Transfusions of blood products increase perioperative complications and reduce graft and patients survival.
The primary endpoint of the study is to evaluate the incidence of renal complication during ICU stay after liver transplantation using RIFLE criteria; secondary endpoint is to evaluate the incidence of cardiovascular and pulmonary complications. In addition patients' survival and the relationship between blood components use with the development of post-operative complications are evaluated.
详细描述
It is conducted a prospective observational cohort study in all Italian liver transplant centers. Adult (> 18 years old) recipients of deceased liver graft between January 2011 and December 2013 were eligible for inclusion. Exclusion criteria were the use of living organ donation, retransplantation, pediatric transplantations, combined transplantation and fulminant hepatic failure.
Investigators collected data using a prospectively maintained computer database managed by the Italian Ministry of Health "Centro Nazionale Trapianti". Anesthetic and perioperative management followed the routine local institution protocols.
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
- 否
入选标准
- •18 years old or more
排除标准
- •Age less than 18 years;
- •Liver transplantation living related donor;
- •Retransplantation;
- •combined transplantation;
- •fulminant hepatic failure;
结局指标
主要结局
Incidence of renal complication after liver transplantation
时间窗: At 72 post operative hours
The primary endpoint of the study is to evaluate the incidence of renal complication during ICU stay after liver transplantation using RIFLE criteria
次要结局
- Incidence of cardiovascular complication after liver transplantation(During ICU length of stay, an average of 4 days.)
- Number of patients alive after liver transplantation that required blood components transfusion(At 1 year and at 3 years after liver transplantation)
- Incidence of pulmonary complication after liver transplantation(During ICU length of stay, an average of 4 days.)
研究者
Giorgio Della Rocca
Full Professor
Azienda Ospedaliera S. Maria della Misericordia