The Impact of Postoperative Oxygen Therapy on the Results of Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 193
- 试验地点
- 2
- 主要终点
- Number of patients with postoperative infections
研究概览
简要总结
The aim of this prospective randomized controlled trial is to evaluate the impact of high concentration supplemental postoperative oxygen therapy on short-term and long-term results of liver transplantation, particularly with respect to infections and biliary complications.
详细描述
The aim of this prospective randomized controlled trial is to evaluate the impact of high concentration supplemental postoperative oxygen therapy on short-term and long-term results of liver transplantation, particularly with respect to infections and biliary complications. A total of 296 patients immediately after liver transplantation will be randomly assigned to receive either 80% (high concentration) or 28% (controls) fraction of inspired oxygen for 6 hours after surgery with a 1:1 allocation ratio. Patients will be blinded to the type of received intervention. Randomization will be stratified by the Child-Turcotte-Pugh classification. Both groups will be compared to short- and long-term outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •active liver transplant waitlist status
排除标准
- •active infection at the time of transplantation
- •malignancy
- •cardiac arrest during transplantation
- •chronic obstructive pulmonary disease
- •acute myocardial infarction
结局指标
主要结局
Number of patients with postoperative infections
时间窗: 30 days
Occurrence of postoperative infection defined according to the Centers for Disease Control and Prevention (Am J Infect Control 2008; 36: 309-32)
次要结局
- Graft survival(5 years)
- International normalized ratio(5 days)
- Serum alanine aminotransferase activity(5 days)
- Postoperative hospital stay(1 year)
- Biliary complications(5 years)
- Severe postoperative complications(90 days)
- Patient survival(5 years)
- Serum aspartate aminotransferase activity(5 days)
- Postoperative intensive care unit stay(1 year)
- Serum bilirubin concentration(5 days)
- Postoperative mortality(90 days)
- Early allograft dysfunction(7 days)
- Pulmonary complications(30 days)