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碳酸氢钠用于长时间心肺复苏期间严重代谢性酸中毒的治疗:一项双盲、随机、安慰剂对照的前瞻性研究。

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

作者信息

Ahn Shin, Kim Youn-Jung, Sohn Chang Hwan, Seo Dong Woo, Lim Kyoung Soo, Donnino Michael W, Kim Won Young

机构信息

Department of Emergency Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.

Division of Pulmonary and Critical Care, Department of Emergency Medicine and Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.

出版信息

J Thorac Dis. 2018 Apr;10(4):2295-2302. doi: 10.21037/jtd.2018.03.124.

Abstract

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 6.90, P=0.038) and bicarbonate levels (21.0 8.0 mEq/L, P=0.007). However, no significant differences showed between sodium bicarbonate and placebo groups in sustained ROSC (4.0% 16.0%, P=0.349) or good neurologic survival at 1 month (0.0% 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.

TRIAL REGISTRATION

NCT02303548 (http://www.ClinicalTrials.gov).

摘要

背景

在心肺复苏(CPR)期间给予碳酸氢钠存在争议。当前指南推荐在已有代谢性酸中毒的患者中注射碳酸氢钠,但临床试验,尤其是涉及酸中毒患者的试验有限。我们旨在评估在长时间CPR期间,给予碳酸氢钠对院外心脏骤停(OHCA)合并严重代谢性酸中毒患者的疗效。

方法

2015年1月至2015年12月在一个中心急诊科进行了前瞻性、双盲、随机安慰剂对照的试点试验。在CPR 10分钟后,纳入未实现自主循环恢复(ROSC)且伴有严重代谢性酸中毒(pH<7.1或碳酸氢根<10 mEq/L)的患者。给予碳酸氢钠(n = 25)或生理盐水(n = 25)。主要终点是持续性ROSC。次要终点是酸中毒的变化和良好的神经功能存活情况。

结果

碳酸氢钠组对pH(6.99±6.90,P = 0.038)和碳酸氢根水平(21.0±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性ROSC(4.0%±16.0%,P = 0.349)或1个月时良好的神经功能存活情况(0.0%±4.0%,P = 1.000)方面无显著差异。

结论

使用碳酸氢钠改善了酸碱状态,但未提高ROSC率和良好的神经功能存活情况。我们无法得出结论,但我们的试点数据可用于设计更大规模的试验以验证碳酸氢钠的疗效。

试验注册

NCT02303548(http://www.ClinicalTrials.gov)

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