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[NEJM在线发表]:SALT-ED研究显示,平衡盐溶液与生理盐水不影响非危重病患者预后
2018年03月06日 时讯速递, 进展交流 暂无评论

Balanced Crystalloids versus Saline in Noncritically Ill Adults

Wesley H. Self, Matthew W. Semler, Jonathan P. Wanderer, et al

N Engl J Med February 27, 2018

DOI: 10.1056/NEJMoa1711586

Abstract

BACKGROUND 背景

Comparative clinical effects of balanced crystalloids and saline are uncertain, particularly in noncritically ill patients cared for outside an intensive care unit (ICU).

平衡盐溶液与生理盐水临床疗效的比较结果尚不确切,尤其在ICU之外的非危重病患者。

METHODS 方法

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.

我们进行了一项单中心、实效性、多重交叉临床试验,以比较平衡盐溶液(乳酸林格氏液或Plasma-Lyte)与生理盐水对急诊科就诊后未收入ICU的成年患者的疗效。在为期16个月的临床试验中,根据所在月份确定急诊科患者静脉输液所使用的晶体液种类(平衡盐溶液和生理盐水相互交替)。主要预后指标为非住院日(28天内出院后存活天数)。次要预后指标包括30天内重要不良肾脏事件—这是一项复合指标,包括任何原因导致死亡,新发肾脏替代治疗或持续肾脏功能障碍(定义为肌酐水平较基线值升高≥200%)—均在出院时或30天时截尾。

RESULTS 结果

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).

研究共入选13347名患者,在急诊科期间输注晶体液量中位数为1079 ml,88.3%的患者仅输注了指定的晶体液。平衡盐溶液组与生理盐水组非住院日并无差异(中位数均为25天;平衡盐溶液组校正后比数比0.98; 95% 可信限 [CI], 0.92 to 1.04; P=0.41)。与生理盐水相比,平衡盐溶液组30天内重要不良肾脏事件发生率显著降低(4.7% vs. 5.6%;校正比数比 0.82; 95% CI, 0.70 to 0.95; P=0.01)。

CONCLUSIONS 结论

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.)

对于在急诊科接受静脉输液治疗的成年非危重病患者,使用平衡盐溶液与生理盐水治疗并不导致非住院日的差异。

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