Regional citrate versus systemic heparin anticoagulation for continuous renal replacement therapy in critically ill patients with acute kidney injury (RICH) trial: study protocol for a multicentre, randomised controlled trial
Regional citrate versus systemic heparin anticoagulation for continuous renal replacement therapy in critically ill patients with acute kidney injury (RICH) trial: study protocol for a multicentre, randomised controlled trial
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DOI：
10.1136/bmjopen-2018-024411
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发表时间：
2019-06-01
期刊：
影响因子：
2.9
通讯作者：
Zarbock, Alexander
中科院分区：
文献类型：
--
作者：
Meersch, Melanie;Kuellmar, Mira;Zarbock, Alexander
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至关重要。肾脏替代治疗（RRT）不可避免地会增加治疗复杂性，并增加重度阿基患者的成本。然而，目前尚不清楚连续RRT（CRRT）的局部柠檬酸盐抗凝或全身肝素抗凝是否最合适。我们假设，与全身肝素抗凝相反，CRRT的局部柠檬酸盐抗凝延长了滤器寿命，并提高了90天随访期内的总生存率（共同主要终点）。方法和分析我们将进行一项前瞻性、随机、多中心临床试验，包括多达1450例需要CRRT的阿基危重患者。我们建议研究CRRT中局部柠檬酸盐抗凝与全身肝素抗凝相比的效果。两个共同主要结局是90天随访期内的滤器寿命和总生存期。次要结局是重症监护室的住院时间;住院时间; CRRT持续时间;第28、60、90和1年时肾功能恢复;第28、60、90和1年后需要RRT; 28、60、90天和1年全因死亡率;第28、60、90和1年时的主要不良肾脏事件;出血并发症;输血需求;感染率和RRT费用。此外，在一项涉及几个参与中心的附加研究中，将在不同时间点从招募的患者中采集血样，以分析抗凝策略是否对免疫应答有影响，如白细胞募集和功能所证明的。伦理和传播RICH试验已获得联邦药物和医疗器械研究所的批准，明斯特大学的主要伦理委员会和每个参与研究中心的相应伦理委员会。
Introduction Acute kidney injury (AKI) is a wellrecognised complication of critical illness which is of crucial importance for morbidity, mortality and health resource utilisation. Renal replacement therapy (RRT) inevitably entails an escalation of treatment complexity and increases costs for those patients with severe AKI. However, it is still not clear whether regional citrate anticoagulation or systemic heparin anticoagulation for continuous RRT (CRRT) is most appropriate. We hypothesise that, in contrast to systemic heparin anticoagulation, regional citrate anticoagulation for CRRT prolongs filter life span and improves overall survival in a 90-day follow-up period (coprimary endpoints).Methods and analysis We will conduct a prospective, randomised, multicentre, clinical trial including up to 1450 critically ill patients with AKI requiring CRRT. We suggest to investigate the effect of regional citrate anticoagulation for CRRT as compared with systemic heparin anticoagulation. The two coprimary outcomes are filter life span and overall survival in a 90-day follow-up period. Secondary outcomes are length of stay in the intensive care unit; length of hospitalisation; duration of CRRT; recovery of renal function at days 28, 60, 90 and 1 year; requirement for RRT after days 28, 60, 90 and 1 year; 28 days, 60 days, 90 days and 1-year all-cause mortality; major adverse kidney events at days 28, 60, 90 and 1 year; bleeding complications; transfusion requirements; infection rate and costs of RRT. Additionally, in an add-on study involving several of the participating centres, blood samples from recruited patients will be collected at different time points to analyse whether the anticoagulation strategy has an impact on immune response as evidenced by leucocyte recruitment and function.Ethics and dissemination The RICH trial has been approved by the Federal Institute for Drugs and Medical Devices, the leading Ethics Committee of the University of Munster and the corresponding Ethics Committee at each participating site.