Effectiveness and Safety Evaluation of Nafamostat Mesilate During Continuous Renal Replacement Therapy in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- the average filter life-span
研究概览
简要总结
Continuous renal replacement therapy is widely used in intensive care medicine, which is known as an alternative therapy to save injured kidney . Anticoagulation is an important part of this therapy. An insufficient anticoagulation would cause a poor curative effect of CRRT. Hemorrhage，heparin-induced thrombocytopenia (HIT), citrate accumulation, acidosis ad filter extra-cost usually happened on anticoagulation during CRRT. Therefore a new effective anticoagulation of CRRT needs to be carried out. Nafamostat Mesylate (NM) is a new anticoagulant. This serine protease inhibitor with broad spectrum can inhibit kinds of enzymes on the process of coagulation. NM is mainly rapidly decomposed in the liver and also removed by dialysis or filtration. The elimination half life of is only 8 minutes. If NM is applied as a regional anticoagulant, approximate 40% NM is removed by dialysis and / or convection in cardiopulmonary bypass circuit, and then rapidly degraded by esterase in liver and blood, which ensures security in patients with bleeding tendency.
Based on the information above, the investigators designed an observational clinical study aimed to testify that NM would have equivalent anticoagulant results compared with those traditional ways and might even have a better effect than traditional anticoagulant therapy.The study team has investigated the current situation of CRRT in Shaanxi province in China through a cross-sectional survey last year. The survey involved 74 hospitals in Shaanxi province and the results basically illustrated a real status of CRRT. These scientific results helped investigators to design this multi-center, parallel, controlled, non intervention study and real world study.
详细描述
CRRT, the continuous renal replacement therapy, is widely applied in the field of intensive care medicine. This technology is known as an alternative therapy to save injured kidney with advantages of the accurate volume control, stable acid-alkali electrolyte equilibrium maintenance and hemodynamic stability.
Anticoagulation is an important part of this therapy. An ideal anticoagulant and a reasonable anticoagulation process would help CRRT function well. Therefor an insufficient anticoagulation would cause a poor curative effect of CRRT.
Heparins, reginal citrate anticoagulant (RCA) and anticoagulant-free are the most common methods applied in CRRT. However, heparins would lead to hemorrhage and heparin-induced thrombocytopenia (HIT). And RCA is the absolute contraindication of liver failure and shock status, which would easily cause citrate accumulation and acidosis. While anticoagulant-free method is often suitable for patients with acute hepatic failure, citrate metabolic disorder, sever acidosis and coagulation dysfunction. According to aforementioned reasons, a new effective anticoagulation of CRRT needs to be carried out.
Nafamostat Mesylate (NM) is a late-model anticoagulant. This serine protease inhibitor with broad spectrum can inhibit kinds of enzymes on the process of coagulation. It has strong inhibitory effects on thrombin, coagulation factors Ⅻ a, Xa, VIIa, kallikrein, fibrinolytic enzyme, complement system C1r, C1s and trypsin. NM is mainly rapidly decomposed by carboxylesterase in the liver and also removed by dialysis or filtration. The elimination half life of is only 8 minutes. If NM is applied as a reginal anticoagulant, approximate 40% NM is removed by dialysis and / or convection in cardiopulmonary bypass circuit, and then rapidly degraded by esterase in liver and blood, which ensures security in patients with bleeding tendency.
Based on the information above, the investigators designed an observational clinical study aimed to testify that NM would have equivalent anticoagulant results compared with those traditional ways and might even have a better effect than traditional anticoagulant therapy.
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 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critically ill patients admitted to ICU
- •ICU patients requiring further CRRT due to renal or non-renal indications
- •signed informed consent
排除标准
- •The hospitalization stay of ICU is less than 24 hours.
- •The case data are incomplete.
- •age<18 and ≥85
- •patients suffering from metal illness or unable to cooperate for some certain reasons
- •allergic to NM or Pharmaceutical excipient or extracorporeal circuit consumables
- •preparing for pregnancy/pregnant/ during lactation period
- •patients or their agents refuse to sign the informed consent form or participate in another clinical trial
- •non-compliant, lost visit or other situations that patients are unsuitable for selection determined by researchers
结局指标
主要结局
the average filter life-span
时间窗: up to 96 hours
The average filter life-span is calculated as the total life-span of filters devided by filter numbers during the first 96 hours of first CRRT. The metric is described as hour per number.
次要结局
- the incidence of bleeding or massive hemorrhage events(From date of first CRRT start until the date of discharge or death, assessed up to 90 days)