非危重症成年患者使用平衡晶体液与生理盐水的比较。
Balanced Crystalloids versus Saline in Noncritically Ill Adults.
作者信息
Self Wesley H, Semler Matthew W, Wanderer Jonathan P, Wang Li, Byrne Daniel W, Collins Sean P, Slovis Corey M, Lindsell Christopher J, Ehrenfeld Jesse M, Siew Edward D, Shaw Andrew D, Bernard Gordon R, Rice Todd W
机构信息
From the Departments of Emergency Medicine (W.H.S., S.P.C., C.M.S.), Anesthesiology (J.P.W., J.M.E., A.D.S.), Biomedical Informatics (J.P.W., J.M.E.), and Biostatistics (L.W., D.W.B., C.J.L.), the Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine (M.W.S., G.R.B., T.W.R.), and the Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt Center for Kidney Disease and Integrated Program for Acute Kidney Injury Research (E.D.S.), Vanderbilt University Medical Center, Nashville.
出版信息
N Engl J Med. 2018 Mar 1;378(9):819-828. doi: 10.1056/NEJMoa1711586. Epub 2018 Feb 27.
BACKGROUND
Comparative clinical effects of balanced crystalloids and saline are uncertain, particularly in noncritically ill patients cared for outside an intensive care unit (ICU).
METHODS
We conducted a single-center, pragmatic, multiple-crossover trial comparing balanced crystalloids (lactated Ringer's solution or Plasma-Lyte A) with saline among adults who were treated with intravenous crystalloids in the emergency department and were subsequently hospitalized outside an ICU. The type of crystalloid that was administered in the emergency department was assigned to each patient on the basis of calendar month, with the entire emergency department crossing over between balanced crystalloids and saline monthly during the 16-month trial. The primary outcome was hospital-free days (days alive after discharge before day 28). Secondary outcomes included major adverse kidney events within 30 days - a composite of death from any cause, new renal-replacement therapy, or persistent renal dysfunction (defined as an elevation of the creatinine level to ≥200% of baseline) - all censored at hospital discharge or 30 days, whichever occurred first.
RESULTS
A total of 13,347 patients were enrolled, with a median crystalloid volume administered in the emergency department of 1079 ml and 88.3% of the patients exclusively receiving the assigned crystalloid. The number of hospital-free days did not differ between the balanced-crystalloids and saline groups (median, 25 days in each group; adjusted odds ratio with balanced crystalloids, 0.98; 95% confidence interval [CI], 0.92 to 1.04; P=0.41). Balanced crystalloids resulted in a lower incidence of major adverse kidney events within 30 days than saline (4.7% vs. 5.6%; adjusted odds ratio, 0.82; 95% CI, 0.70 to 0.95; P=0.01).
CONCLUSIONS
Among noncritically ill adults treated with intravenous fluids in the emergency department, there was no difference in hospital-free days between treatment with balanced crystalloids and treatment with saline. (Funded by the Vanderbilt Institute for Clinical and Translational Research and others; SALT-ED ClinicalTrials.gov number, NCT02614040 .).
背景
平衡晶体液和生理盐水的比较临床效果尚不确定，尤其是在重症监护病房（ICU）以外接受治疗的非重症患者中。
方法
我们进行了一项单中心、实用、多次交叉试验，比较平衡晶体液（乳酸林格氏液或Plasma-Lyte A）与生理盐水在急诊科接受静脉晶体液治疗且随后在ICU以外住院的成年人中的效果。根据日历月份为每位患者分配在急诊科使用的晶体液类型，在为期16个月的试验中，整个急诊科每月在平衡晶体液和生理盐水之间交叉。主要结局是无住院天数（出院后至第28天前存活的天数）。次要结局包括30天内的主要不良肾脏事件——由任何原因导致的死亡、新的肾脏替代治疗或持续性肾功能障碍（定义为肌酐水平升高至基线的≥200%）的复合结局——均在出院或30天（以先发生者为准）时进行截尾。
结果
共纳入13347例患者，急诊科给予的晶体液中位数体积为1079 ml，88.3%的患者仅接受分配的晶体液。平衡晶体液组和生理盐水组的无住院天数无差异（每组中位数均为25天；平衡晶体液的调整优势比为0.98；95%置信区间[CI]为0.92至1.04；P=0.41）。平衡晶体液导致30天内主要不良肾脏事件的发生率低于生理盐水（4.7%对5.6%；调整优势比为0.82；95%CI为0.70至0.95；P=0.01）。
结论
在急诊科接受静脉输液治疗的非重症成年人中，平衡晶体液治疗和生理盐水治疗的无住院天数无差异。（由范德比尔特临床与转化研究所以及其他机构资助；SALT-ED临床试验注册号，NCT02614040。）
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