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Regionale citrate versus systemic heparin anticoagulation for continuous renal replacement therapy in critically ill patients with acute kidney injury (RICH-Trial)

局部柠檬酸盐与全身肝素抗凝治疗急性肾损伤危重患者的连续肾脏替代治疗（RICH 试验）

基本信息

批准号：
261065607
负责人：
Professor Dr. Alexander Zarbock
金额：
--
依托单位：
Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
依托单位国家：
德国
项目类别：
Clinical Trials
财政年份：
2015
资助国家：
德国
起止时间：
2014-12-31 至 2021-12-31
项目状态：
已结题

来源：
https://gepris.dfg.de/gepris/projekt/261065607?language=en
关键词：
Regionale citrate versus systemic heparin

项目摘要

Acute kidney injury (AKI) is a well-recognized complication of critical illness with an important impact on morbidity, mortality, and health resource utilization. Renal replacement therapy (RRT) causes a considerable escalation in the complexity of treatment, has inherent risks for adverse effects and increases cost of care for those with severe AKI. To this date it is not clear whether regional citrate anticoagulation or systemic heparin anticoagulation for CRRT should be used. We hypothesize that regional citrate anticoagulation for CRRT prolongs filter life and decreases the 90-day all cause mortality compared to the use of systemic heparin anticoagulation. We will conduct a prospective, randomized, multicenter, controlled trial including 1450 critically ill patients with AKI requiring CRRT. We propose to investigate the effect of regional citrate anticoagulation for CRRT compared to systemic heparin anticoagulation for CRRT. The primary outcome parameters are the filter life and the overall survival in a 90-day follow-up period (90-day all cause mortality). Secondary endpoints are the length of stay on the intensive care unit, length of hospitalization, duration of renal replacement therapy, recovery of renal function, requirement for hemodialysis after day 28 and day 60, 28-day all cause mortality, 60-day all cause mortality, 1-year mortality, bleeding complications, transfusion requirements, rate of infection, and cost analysis of renal replacement therapy. Additionally in an add-on study involving several centers, blood samples from recruited patients will collected and analyzed. As the currently available data on the topic is inconclusive, this prospective, randomized, multicenter trial is needed to provide evidence for the best anticoagulation regimen for CRRT in critically ill patients with AKI.

急性肾损伤（阿基）是一种公认的危重病并发症，对发病率、死亡率和卫生资源利用有重要影响。肾脏替代疗法（RRT）导致治疗复杂性显著增加，具有不良反应的固有风险，并增加了重度阿基患者的护理成本。迄今为止，尚不清楚CRRT应使用局部柠檬酸盐抗凝还是全身肝素抗凝。我们假设，与使用全身肝素抗凝相比，CRRT的局部柠檬酸盐抗凝延长了滤器寿命并降低了90天全因死亡率。我们将进行一项前瞻性、随机、多中心、对照试验，纳入1450例需要CRRT的阿基重症患者。我们建议研究CRRT中局部柠檬酸盐抗凝与CRRT中全身肝素抗凝相比的效果。主要结局参数为滤器寿命和90天随访期内的总生存率（90天全因死亡率）。次要终点是重症监护室的住院时间、住院时间、肾脏替代治疗的持续时间、肾功能恢复、第28天和第60天后的血液透析需求、28天全因死亡率、60天全因死亡率、1年死亡率、出血并发症、输血需求、感染率和肾脏替代治疗的成本分析。此外，在涉及多个中心的附加研究中，将采集并分析招募患者的血液样本。由于目前关于该主题的可用数据不确定，因此需要这项前瞻性、随机化、多中心试验为阿基重症患者CRRT的最佳抗凝方案提供证据。