A Comparative Study of Safety and Efficacy of Nafamostat Mesylate and Unfractionated Heparin in Renal Replacement Therapy for Sepsis Associated Acute Kidney Injury: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Platelet decline rate
研究概览
简要总结
The goal of this clinical trial is to compare the safety and efficacy of nafamostat mesylate (NM) and unfractionated heparin (UFH) in the process of renal replacement therapy (RRT) for patients suffering from sepsis associated acute kidney injury (SA-AKI). The main questions it aims to answer are:
The impact of NM and UFH on platelet count in septic patients undergoing RRT treatment.
The satisfaction with anticoagulation of NM and UFH in septic patients undergoing RRT treatment.
The 28-day all-cause mortality rate of septic patients undergoing RRT treatment with NM and UFH.
Researchers will use NM or UFH as anticoagulation during RRT in SA-AKI patients, assessing effects on platelet count, anticoagulation satisfaction, and mortality.
Participants will receive NM or UFH as anticoagulation during RRT for a minimum of 7 days. Bleeding symptoms, platelet count and coagulation function will be monitored daily. Platelet changes during the 7-day treatment period and survival status at 28 days post-treatment will be recorded.
详细描述
- Research Description:
This study is a prospective, randomized, parallel-controlled, blinded endpoint clinical trial. It aims to compare the safety and efficacy of NM and UFH in the process of RRT for septic patients. 2. Sample Size Calculation:
The study design is an equivalence study. Based on relevant literature, the degree of platelet decrease caused by NM is approximately 20.9% ± 5%, and the degree of platelet decrease associated with UFH is approximately 23.3% ± 5%. The study compares the difference between these two rates at a significance level of 0.05 and a power of 80%. Therefore, the calculated sample size is 70 participants per group, with a 10% dropout rate considered, resulting in a total sample size of 156 participants (78 participants per group). 3. Adverse Event Recording:
The adverse events in this study primarily include unplanned discontinuation of RRT (due to vascular access failure, filter clotting, or unstable vital signs). We will rigorously document the occurrence of adverse events and provide appropriate management. For serious adverse events resulting from platelet decrease, the study may be terminated early if platelet count drops below 25 × 10^9/L, decreases by more than 50% from baseline, or if active bleeding (digestive tract, skin mucosa, urinary tract, airway, etc.) occurs. 4. Statistical Analysis:
The intention-to-treat (ITT) population is defined as the set of patients who received at least one intervention after randomization. ITT analysis is the primary analysis for this study. The primary endpoint will be analyzed using analysis of covariance (ANCOVA). Anticoagulation satisfaction will be assessed using the Cochran-Mantel-Haenszel (CMH) test. The 28-day all-cause mortality rate will be analyzed using survival analysis, with survival described by Kaplan-Meier curves and compared by log-rank test. Cox regression will be used to assess the impact of NM and UFH on survival after adjusting for other confounding factors. A two-sided p-value <0.05 will be considered statistically significant.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 14 years old, and ≤ 90 years old.
- •Sepsis or septic shock.
- •AKI (Acute Kidney Injury), with stage of 2-
- •Received renal replacement therapy (RRT) for ≥ 24 hours.
- •Survival time ≥ 48 hours.
排除标准
- •Presence of bleeding tendency or active bleeding.
- •Pre-existing chronic kidney disease or already undergoing routine hemodialysis.
- •With liver failure, severe hematologic disorders, malignancies, or other significant underlying diseases
- •Pre-using of anticoagulant or antiplatelet medications such as aspirin, clopidogrel, rivaroxaban, dabigatran, or ticagrelor
- •Allergy to heparin or nafamostat mesylate.
- •Survival time < 48 hours or RRT treatment time < 24 hours.
- •Initial platelet count < 50 × 10^9/L.
- •Participation in another clinical trial within the past 1 month.
研究组 & 干预措施
Nafamostat
Patients in NM arm will receive nafamostat mesylate as as anticoagulation during renal replacement therapy.
干预措施: Nafamostat Mesylate (Drug)
Heparin
Patients in UFH arm will receive unfractionated heparin as as anticoagulation during renal replacement therapy.
干预措施: Unfractionated Heparin (Drug)
结局指标
主要结局
Platelet decline rate
时间窗: 7 days after initiation of RRT treatment
(baseline platelet count - day 7 platelet count)/baseline platelet count \*100%
次要结局
- Satisfaction of filter anticoagulation(7 days after initiation of RRT treatment)
研究者
Shen Lei
Chief Physician
Huashan Hospital