Sodium bicarbonate on severe metabolic acidosis during prolonged cardiopulmonary resuscitation: a double-blind, randomized, placebo-controlled pilot study

Sodium bicarbonate on severe metabolic acidosis during prolonged cardiopulmonary resuscitation: a double-blind, randomized, placebo-controlled pilot study
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DOI:
10.21037/jtd.2018.03.124
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发表时间:
2018-04-01
影响因子:
2.5
通讯作者:
Kim, Won Young
Kim, Won Young
中科院分区:
医学4区
文献类型:
--
作者:
Ahn, Shin;Kim, Youn-Jung;Kim, Won Young

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背景:心肺复苏(CPR)过程中碳酸氢钠的使用是有争议的。目前的指南建议对存在代谢性酸中毒的患者注射碳酸氢钠,但临床试验,特别是涉及酸中毒患者的临床试验,是有限的。我们的目的是评估碳酸氢钠在院外心脏骤停(OHCA)患者长时间心肺复苏期间严重代谢性酸中毒的疗效。方法:于2015年1月至2015年12月在某单中心急诊科(ED)进行前瞻性、双盲、随机、安慰剂对照先导试验。在心肺复苏术10分钟后,未实现自然循环恢复(ROSC)且伴有严重代谢性酸中毒(pH < 7.1或碳酸氢盐< 10 mEq/L)的患者入组。给予碳酸氢钠(n = 25)或生理盐水(n = 25)。主要终点为持续ROSC。次要终点为酸中毒的改变和良好的神经系统生存。结果:碳酸氢钠组对pH (6.99 vs. 6.90, P = 0.038)和碳酸氢钠水平(21.0 vs. 8.0 mEq/L, P = 0.007)有显著影响。然而,碳酸氢钠组和安慰剂组在持续ROSC (4.0% vs. 16.0%, P = 0.349)或1个月的良好神经系统生存率(0.0% vs. 4.0%, P = 1.000)方面没有显着差异。结论:碳酸氢钠的使用改善了酸碱状态,但没有改善ROSC的发生率和良好的神经系统生存率。我们无法得出结论,但我们的试验数据可以用来设计一个更大的试验来验证碳酸氢钠的功效。
Background: Sodium bicarbonate administration during cardiopulmonary resuscitation (CPR) is controversial. Current guidelines recommend sodium bicarbonate injection in patients with existing metabolic acidosis, but clinical trials, particularly, those involving patients with acidosis, are limited. We aimed to evaluate the efficacy of sodium bicarbonate administration in out-of-hospital cardiac arrest (OHCA) patients with severe metabolic acidosis during prolonged CPR.Methods: Prospective, double-blind, randomized placebo-controlled pilot trial was conducted between January 2015 and December 2015, at a single center emergency department (ED). After 10 minutes of CPR, patients who failed to achieve return of spontaneous circulation (ROSC) and with severe metabolic acidosis (pH < 7.1 or bicarbonate < 10 mEq/L) were enrolled. Sodium bicarbonate (n = 25) or normal saline (n = 25) were administered. The primary end point was sustained ROSC. The secondary end points were the change of acidosis and good neurologic survival.Results: Sodium bicarbonate group had significant effect on pH (6.99 vs. 6.90, P = 0.038) and bicarbonate levels (21.0 vs. 8.0 mEq/L, P = 0.007). However, no significant differences showed between sodium bicarbonate and placebo groups in sustained ROSC (4.0% vs. 16.0%, P = 0.349) or good neurologic survival at 1 month (0.0% vs. 4.0%, P = 1.000).Conclusions: The use of sodium bicarbonate improved acid-base status, but did not improve the rate of ROSC and good neurologic survival. We could not draw a conclusion, but our pilot data could be used to design a larger trial to verify the efficacy of sodium bicarbonate.