Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta,12 Walter C, Mackenzie Centre, 8440-112 Street, Edmonton, Alberta, Canada.
Trials. 2010 May 11;11:50. doi: 10.1186/1745-6215-11-50.
Furosemide is commonly prescribed in critically ill patients with acute kidney injury (AKI). Existing data from observational studies and small clinical trials have significant limitations and have reported conflicting findings. There remains controversy on whether furosemide can impact clinical outcomes in critically ill patients with AKI; however, a survey of intensivists and nephrologists showed equipoise for high-quality evidence on this important issue.
DESIGN/METHODS: This protocol summarizes the rationale and design of a phase II randomized, blinded, placebo-controlled trial of a low-dose continuous infusion of furosemide, titrated to the physiology parameter of urine output, in critically ill patients with early AKI. Two hundred sixteen adult critically ill patients with early evidence of AKI, defined by the RIFLE criteria, will be enrolled. Included patients will also have fulfilled >or=2 criteria of the systemic inflammatory response syndrome and achieved immediate goals of acute resuscitation. The primary outcome is progression in severity of kidney injury. Secondary outcomes include: safety, fluid balance, electrolyte balance, the need for renal replacement therapy, duration of AKI, rate of renal recovery, mortality and changes in novel serum and urine biomarkers of AKI. The primary analysis will be intention-to-treat. Planned recruitment will be complete by June 2011 and results available by December 2011.
ClinicalTrials.gov Identifier NCT00978354.
速尿常用于伴有急性肾损伤（AKI）的重症患者。来自观察性研究和小型临床试验的数据存在很大局限性，且报告的结果相互矛盾。速尿是否能影响伴有 AKI 的重症患者的临床结局仍存在争议；但是，对重症监护医师和肾病学家的调查显示，对于这个重要问题，他们对高质量证据持均衡观点。
设计/方法：本方案总结了一项低剂量持续输注速尿的 II 期随机、双盲、安慰剂对照试验的原理和设计，该试验针对的是伴有早期 AKI 的重症患者的尿量生理参数进行滴定。将招募 216 例伴有早期 AKI 的成年重症患者，AKI 的证据由 RIFLE 标准定义。纳入的患者还需要满足全身性炎症反应综合征的 >或=2 项标准，并达到急性复苏的即刻目标。主要结局是肾损伤严重程度的进展。次要结局包括：安全性、液体平衡、电解质平衡、需要肾脏替代治疗、AKI 的持续时间、肾脏恢复的速度、死亡率和 AKI 的新型血清和尿液生物标志物的变化。主要分析将是意向治疗。计划于 2011 年 6 月前完成招募，2011 年 12 月前可获得结果。
ClinicalTrials.gov 标识符：NCT00978354。
