Effect of Nafamostat Mesilate on Hemodynamic Stability After Reperfusion of the Liver Graft
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS)
研究概览
简要总结
This study intends to see the effect of nafamostat on the attenuation of postreperfusion syndrome (PRS) that frequently occurs during liver transplantation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 18 year old scheduled to undergo liver transplantation
排除标准
- •Previous history of pulmonary, cardiovascular, or renal disease
- •Previous history of allergic reactions to nafamostat
研究组 & 干预措施
nafamostat
The Nafamostat mesilate group received 0.2 mg/kg of nafamostat mesilate intravenously 1 min before reperfusion of the liver graft.
干预措施: Nafamostat (Drug)
Control
The control group received 10 ml of normal saline (same volume as nafamostat)intravenously 1 min before reperfusion of the liver graft.
干预措施: Normal saline (Drug)
结局指标
主要结局
Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS)
时间窗: during 5 min after reperfusion of liver graft
Before entering the study, we re-defined the criteria of PRS. From our clinical experiences, two types of PRS were observed according to its severity and treatment option. "Moderate" PRS was identical to previously defined PRS: more than 30% decrease of mean arterial pressure lasting over 1 min was observed within 5 min after reperfusion of the liver graft. However, we differentiated a "severe" form of PRS, in which MAP rapidly fell below 40 mmHg, from the moderate one, because severe PRS required prompt intervention to prevent a permanent damage of vital organs.
次要结局
未报告次要终点