Hepatic Vein Flow Assessment With Transesophageal Echocardiography for Postoperative Graft Function Prediction in Orthotopic Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- EAD
研究概览
简要总结
Hepatic vein flow (HVF) assessment using transesophageal echocardiography (TEE) has a potential to predict postoperative graft function in orthotopic liver transplant (OLT). Investigators will measure HVF using TEE and assess the correlation with postoperative graft function indices such as early allograft dysfunction(EAD), prolonged INR, platelet, and total bilirubin.
详细描述
During OLT, intraoperative TEE assessment of HVF (systolic and diastolic) were measured, and adjusted with donor graft weight. This index, HVF index, was assessed for correlation with EAD. HVF was calculated with hepatic vein area (cm2) x hepatic vein velocity (ml/s) in systole and diastole during the neohepatic phase. Investigators did ROC analysis to assess the predictive power for EAD, prolonged INR, platelet, and total bilirubin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Orthotopic liver transplants which uses TEE intraoperatively Must be Piggy back technique
排除标准
- •TEE absolute contraindication patient refusal
结局指标
主要结局
EAD
时间窗: EAD met at any point within the first 7 days status post OLT
Primary outcome was early allograft dysfunction (EAD), which was defined by the presence of one or more of the following: total bilirubin (t-bil) ≥ 10 mg/dL (171 μmol/L) or, INR ≥ 1.6 on postoperative day 7. and ALT/AST \> 2,000 IU/L Systolic and diastolic hepatic vein flow index was assessed intraoperatively in neohepatic phase in both of EAD and non EAD group, and reported.
次要结局
- Acute Rejection(Acute rejection noted at any point within 6-8 weeks post transplant)
- Prolonged (>Seven Days) Time to Normalize Total Bilirubin (TIME T-bil)(postoperative day 7 assessment)
- Prolonged (>Seven Days) Time to Normalize INR (TIME Inr)(postoperative day 7 assessment)
- Prolonged (>Seven Days) Time to Normalize Platelet Count (TIME Plt).(postoperative day 7 assessment)
研究者
Yoshihisa Morita
MD
Henry Ford Health System