Gould Doug W, Doidge James, Zia Sadique M, Borthwick Mark, Caskey Fergus J, Forni Lui, Lawrence Robert F, MacEwen Clare, Mouncey Paul R, Ostermann Marlies, Harrison David A, Rowan Kathryn M, Duncan Young J, Watkinson Peter J
Clinical Trials Unit, Intensive Care National Audit & Research Centre (ICNARC), London, UK.
Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.
J Intensive Care Soc. 2022 Aug;23(3):311-317. doi: 10.1177/1751143720913417. Epub 2020 Apr 2.
Acute kidney injury is common in critical illness. In patients with severe acute kidney injury, renal replacement therapy is needed to prevent harm from metabolic and electrolyte disturbances and fluid overload. In the UK, continuous renal replacement therapy (CRRT) is the preferred modality, which requires anticoagulation. Over the last decade, conventional systemic heparin anticoagulation has started being replaced by regional citrate anticoagulation for CRRT, which is now used in approximately 50% of ICUs. This shift towards regional citrate anticoagulation for CRRT is occurring with little evidence of safety or longer term effectiveness. Renal replacement anticoagulant management (RRAM) is an observational comparative effectiveness study, utilising existing data sources to address the clinical and cost-effectiveness of the change to regional citrate anticoagulation for CRRT in UK ICUs. The study will use data from approximately 85,000 patients who were treated in adult, general ICUs participating in the case mix programme national clinical audit between 1 April 2009 and 31 March 2017. A survey of health service providers' anticoagulation practices will be combined with treatment and hospital outcome data from the case mix programme and linked with long-term outcomes from the Civil Registrations (deaths), Hospital Episodes Statistics for England, Patient Episodes Data for Wales, and the UK Renal Registry datasets. The primary clinical effectiveness outcome is all-cause mortality at 90-days. The study will incorporate an economic evaluation with micro-costing of both regional citrate anticoagulation and systemic heparin anticoagulation. Study registration: NCT03545750.
急性肾损伤在危重症中很常见。对于严重急性肾损伤患者，需要进行肾脏替代治疗以预防代谢和电解质紊乱以及液体过载带来的危害。在英国，连续性肾脏替代治疗（CRRT）是首选方式，这需要抗凝。在过去十年中，CRRT的传统全身肝素抗凝已开始被局部枸橼酸盐抗凝所取代，目前约50%的重症监护病房（ICU）都在使用后者。向CRRT的局部枸橼酸盐抗凝转变时，几乎没有安全性或长期有效性的证据。肾脏替代抗凝管理（RRAM）是一项观察性比较有效性研究，利用现有数据源来探讨英国ICU中CRRT改用局部枸橼酸盐抗凝的临床和成本效益。该研究将使用2009年4月1日至2017年3月31日期间参与病例组合计划国家临床审计的成人综合ICU中接受治疗的约85000名患者的数据。对医疗服务提供者抗凝实践的调查将与病例组合计划中的治疗和医院结局数据相结合，并与民事登记（死亡）、英格兰医院事件统计、威尔士患者事件数据以及英国肾脏注册数据集的长期结局相关联。主要临床有效性结局是90天全因死亡率。该研究将纳入一项经济评估，对局部枸橼酸盐抗凝和全身肝素抗凝进行微观成本核算。研究注册：NCT03545750。
