The Effect of Nafamostat Mesilate in Prolonging Filter Patency With Patients on Continuous Renal Replacement Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
Continuous renal replacement therapy (CRRT) has been considered as an effective modality for renal replacement therapy in hemodynamically unstable patients within intensive care unit (ICU) except for the necessity of anticoagulation. The severity and peculiarities of ICU patients often make it equivocal to use anticoagulation. This is a prospective randomized controlled study to show the difference in filter life span and adverse event between HF1000 (nafamostat mesilate) group and M100 (heparin-free) group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who have at least one of the hemorrhagic tendencies of following conditions and needs CRRT hemodynamically;
- •Platelet count < 100,000
- •aPTT > 60 sec
- •PT-INR > 2.0
- •active hemorrhage
- •surgery within 48 hours
- •cerebral hemorrhage within 3 months or history of major bleeding
- •septic shock or DIC.
排除标准
- •pregnancy, breast feeding, possibility of pregnancy,
- •allergy to nafamostat mesilate,
- •other conditions that physician consider unfit for candidate.
研究组 & 干预措施
M100
heparin free CRRT group
干预措施: Anticoagulation with nafamostat mesilate (Drug)
HF1000
CRRT with nafamostat mesilate anticoagulation group
干预措施: Anticoagulation with nafamostat mesilate (Drug)
结局指标
主要结局
mortality
时间窗: 2 years
Mortality in intensive care unit
次要结局
未报告次要终点