Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock The ANDROMEDA-SHOCK Randomized Clinical Trial
Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock The ANDROMEDA-SHOCK Randomized Clinical Trial
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DOI：
10.1001/jama.2019.0071
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发表时间：
2019-02-19
影响因子：
120.7
通讯作者：
Bakker, Jan
中科院分区：
文献类型：
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作者：
Hernandez, Glenn;Ospina-Tascon, Gustavo A.;Bakker, Jan
败血症休克复苏后异常的外周血流灌注与器官功能障碍和死亡率有关。在败血症休克早期复苏过程中，外周血灌注量作为复苏目标的临床评估的潜在作用尚未建立。目的确定成人败血症休克早期外周灌注性复苏是否比乳酸水平靶向性复苏在降低死亡率方面更有效。设计、设置和参与者在5个国家的28个重症监护病房进行的多中心随机试验。在2017年3月至2018年3月期间纳入了424名感染性休克患者。最后一次随访是在2018年6月12日。介入治疗的患者被随机分为两组，一组采用循序渐进的复苏方案，旨在使毛细血管再充盈时间正常化(n=212)，或使乳酸水平正常化或以每2小时超过20%的速率降低(n=212)。主要结果和测量结果是28天的全因死亡率。根据序贯器官衰竭评估(SOFA)评分(范围0[最好]到24[最差])，次要结果是随机后72小时的器官功能障碍；90天内死亡；28天内机械通气、肾脏替代治疗和无血管加压药天数；重症监护病房和住院时间。结果在424名随机选择的患者(平均年龄63岁；226名女性[53%])中，416名(98%)完成了试验。到第28天，外周灌注组74名患者(34.9%)和乳酸组92名患者(43.4%)死亡(风险比，0.75[95%CI，0.55至1.02]；P=0.06；风险差异，-8.5%[95%CI，-18.2%至1.2%])。在72小时内，外周灌注定向复苏与器官功能障碍减轻相关(平均SOFA评分，5.6[SD，4.3]比6.6[SD，4.7]；平均差值-1.00[95%CI，-1.97至-0.02]；P=.045)。其余6项二次结局无显著差异。没有与治疗方案相关的严重不良反应得到证实。结论在感染性休克患者中，以毛细血管再充盈时间正常化为目标的复苏策略与以血清乳酸水平为目标的复苏策略相比，并不能降低全原因28天的死亡率。(C)2019年美国医学会。版权所有。
IMPORTANCE Abnormal peripheral perfusion after septic shock resuscitation has been associated with organ dysfunction and mortality. The potential role of the clinical assessment of peripheral perfusion as a target during resuscitation in early septic shock has not been established.OBJECTIVE To determine if a peripheral perfusion-targeted resuscitation during early septic shock in adults is more effective than a lactate level-targeted resuscitation for reducing mortality.DESIGN, SETTING, AND PARTICIPANTS Multicenter, randomized trial conducted at 28 intensive care units in 5 countries. Four-hundred twenty-four patients with septic shock were included between March 2017 and March 2018. The last date of follow-up was June 12, 2018.INTERVENTIONS Patients were randomized to a step-by-step resuscitation protocol aimed at either normalizing capillary refill time (n = 212) or normalizing or decreasing lactate levels at rates greater than 20% per 2 hours (n = 212), during an 8-hour intervention period.MAIN OUTCOMES AND MEASURES The primary outcomewas all-cause mortality at 28 days. Secondary outcomes were organ dysfunction at 72 hours after randomization, as assessed by Sequential Organ Failure Assessment (SOFA) score (range, 0 [best] to 24 [worst]); death within 90 days; mechanical ventilation-, renal replacement therapy-, and vasopressor-free days within 28 days; intensive care unit and hospital length of stay.RESULTS Among 424 patients randomized (mean age, 63 years; 226 [53%] women), 416 (98%) completed the trial. By day 28, 74 patients (34.9%) in the peripheral perfusion group and 92 patients (43.4%) in the lactate group had died (hazard ratio, 0.75 [95% CI, 0.55 to 1.02]; P = .06; risk difference, -8.5%[95% CI, -18.2% to 1.2%]). Peripheral perfusion-targeted resuscitation was associated with less organ dysfunction at 72 hours (mean SOFA score, 5.6 [SD, 4.3] vs 6.6 [SD, 4.7]; mean difference, -1.00 [95% CI, -1.97 to -0.02]; P = .045). There were no significant differences in the other 6 secondary outcomes. No protocol-related serious adverse reactions were confirmed.CONCLUSIONS AND RELEVANCE Among patients with septic shock, a resuscitation strategy targeting normalization of capillary refill time, compared with a strategy targeting serum lactate levels, did not reduce all-cause 28-day mortality. (c) 2019 American Medical Association. All rights reserved.