Effect of a Buffered Crystalloid Solution vs Saline on Acute Kidney Injury Among Patients in the Intensive Care Unit The SPLIT Randomized Clinical Trial
Effect of a Buffered Crystalloid Solution vs Saline on Acute Kidney Injury Among Patients in the Intensive Care Unit The SPLIT Randomized Clinical Trial
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DOI：
10.1001/jama.2015.12334
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发表时间：
2015-10-27
影响因子：
120.7
通讯作者：
Bellomo, Rinaldo
中科院分区：
文献类型：
--
作者：
Young, Paul;Bailey, Michael;Bellomo, Rinaldo
重要生理盐水(0.9%氯化钠)是最常用的静脉输液；然而，它的使用可能与急性肾损伤(AKI)和死亡率增加有关。目的确定缓冲晶体与生理盐水对重症监护病房(ICU)患者肾脏并发症的影响。设计和设置2014年4月至2014年10月在新西兰4个ICU进行的双盲、整群随机、双交叉试验。3个ICU为普通内科和外科ICU；1个ICU以心胸和血管外科患者为主。排除已确诊的需要肾脏替代治疗(RRT)的AKI患者。所有2278名符合条件的患者入选；接受缓冲晶体治疗的1162名患者中的1152名(99.1%)和接受生理盐水治疗的1116名患者中的1110名(99.5%)被分析。干预措施参与的ICU被分配一种掩蔽研究液体，生理盐水或缓冲晶体，用于交替治疗7周。两个ICU开始使用一种液体，另外两个开始使用替代液体。发生了两次交叉，因此在28周的研究中，每个ICU使用了两次每种液体。治疗临床医生决定输液的速度和频率。主要结果和测量主要结果是AKI患者的比例(定义为血清肌酐水平至少上升2倍，或血清肌酐水平=3.96 mg/dL，其中>；=0.5 mg/dL)；结果缓冲液结晶组1067名患者中有102名(9.6%)在登记后90天内发生AKI，而生理盐水组1025名患者中有94名(9.2%)在登记后90天内发生AKI(绝对差异，0.4%[95%CI，-2.1%至2.9%]；相对风险[RR]，1.04[95%CI，0.80至1.36]；P=.77)。在缓冲晶组中，1152名患者中有38名患者(3.3%)接受了RRT，而生理盐水组中有38名患者(3.4%)接受了RRT(绝对差异，-0.1%[95%CI，-1.6%至1.4%]；RR，0.96[95%CI，0.62至1.50]；P=.91)。总体而言，缓冲晶组1152名患者中87名(7.6%)和生理盐水组1110名患者中95名(8.6%)在医院死亡(绝对差异，-1.0%[95%CI，-3.3%至1.2%]；RR，0.88[95%CI，0.67至1.17]；P=0.40)。结论和相关性：在ICU接受晶体液体治疗的患者中，与生理盐水相比，使用缓冲晶体并不能降低AKI的风险。还需要进一步的大型随机临床试验来评估在高危人群中的疗效，并衡量临床结果，如死亡率。
IMPORTANCE Saline (0.9% sodium chloride) is the most commonly administered intravenous fluid; however, its use may be associated with acute kidney injury (AKI) and increased mortality.OBJECTIVE To determine the effect of a buffered crystalloid compared with saline on renal complications in patients admitted to the intensive care unit (ICU).DESIGN AND SETTING Double-blind, cluster randomized, double-crossover trial conducted in 4 ICUs in New Zealand from April 2014 through October 2014. Three ICUs were general medical and surgical ICUs; 1 ICU had a predominance of cardiothoracic and vascular surgical patients.PARTICIPANTS All patients admitted to the ICU requiring crystalloid fluid therapy were eligible for inclusion. Patients with established AKI requiring renal replacement therapy (RRT) were excluded. All 2278 eligible patients were enrolled; 1152 of 1162 patients (99.1%) receiving buffered crystalloid and 1110 of 1116 patients (99.5%) receiving saline were analyzed.INTERVENTIONS Participating ICUs were assigned a masked study fluid, either saline or a buffered crystalloid, for alternating 7-week treatment blocks. Two ICUs commenced using 1 fluid and the other 2 commenced using the alternative fluid. Two crossovers occurred so that each ICU used each fluid twice over the 28 weeks of the study. The treating clinician determined the rate and frequency of fluid administration.MAIN OUTCOMES AND MEASURES The primary outcome was proportion of patients with AKI (defined as a rise in serum creatinine level of at least 2-fold or a serum creatinine level of >= 3.96mg/dL with an increase of >= 0.5mg/dL); main secondary outcomes were incidence of RRT use and in-hospital mortality.RESULTS In the buffered crystalloid group, 102 of 1067 patients (9.6%) developed AKI within 90 days after enrollment compared with 94 of 1025 patients (9.2%) in the saline group (absolute difference, 0.4%[95% CI, -2.1% to 2.9%]; relative risk [RR], 1.04 [95% CI, 0.80 to 1.36]; P=.77). In the buffered crystalloid group, RRT was used in 38 of 1152 patients (3.3%) compared with 38 of 1110 patients (3.4%) in the saline group (absolute difference, -0.1% [95% CI, -1.6% to 1.4%]; RR, 0.96 [95% CI, 0.62 to 1.50]; P = .91). Overall, 87 of 1152 patients (7.6%) in the buffered crystalloid group and 95 of 1110 patients (8.6%) in the saline group died in the hospital (absolute difference, -1.0% [95% CI, -3.3% to 1.2%]; RR, 0.88 [95% CI, 0.67 to 1.17]; P=.40).CONCLUSIONS AND RELEVANCE Among patients receiving crystalloid fluid therapy in the ICU, use of a buffered crystalloid compared with saline did not reduce the risk of AKI. Further large randomized clinical trials are needed to assess efficacy in higher-risk populations and to measure clinical outcomes such as mortality.