早期脓毒性休克中的血管加压药或液体
完整摘要 · 中文译文
背景：脓毒性休克早期复苏的最佳方法尚不清楚。在采用较大容积静脉液体恢复灌注与采用早期血管加压药治疗并配合较小容积液体以减少过量液体潜在危害之间，存在均衡性。 方法：我们将因脓毒性休克就诊于急诊科的成年患者随机分配，分别接受限制液体量联合早期血管加压药治疗（血管加压药组）或较大液体量联合延迟血管加压药治疗（液体组），持续至少6小时，最长至24小时。主要结局为从随机化至第90天的存活且未住院天数。 结果：共有1000名患者接受了随机分组，其中499名被分配到血管加压药组，501名被分配到液体组。有37名患者未获得知情同意，因此意向治疗人群剩963名患者（血管加压药组481名，液体组482名）。液体组中有3名患者的主要结局失访。随机分组后最初24小时内，血管加压药组患者接受的静脉液体量少于液体组患者（中位差异，-1108 ml；95%置信区间[CI]，-1395至-850）。血管加压药组接受血管加压药治疗的患者百分比高出18.9个百分点（95% CI，13.3至24.5）。第90天时存活并出院的中位天数为76天（四分位距，55至83），血管加压药组和液体组分别为76天（四分位距，55至82）（差异，0.0天；95% CI，-2.7至2.7；P = 1.00）。两组不良反应事件发生百分比相似，但肺水肿除外（血管加压药组0.6% vs. 液体组5.0%；P<0.001）。 结论：在急诊科就诊的感染性休克成人患者中，与采用较大液体量和较晚使用血管升压药的方法相比，采用限制液体量和早期使用血管升压药的方法并未导致第90天时存活且出院外的天数更多。（由澳大利亚国家健康与医学研究委员会医学研究未来基金和新西兰健康研究委员会资助；ARISE FLUIDS ClinicalTrials.gov编号，NCT04569942。）
完整摘要 · 英文原文
BACKGROUND: The optimal approach to early resuscitation in septic shock is unknown. Equipoise exists between the use of larger volumes of intravenous fluids to restore perfusion and the use of early vasopressor therapy along with smaller volumes of fluids to minimize potential harm from excess fluid. METHODS: We randomly assigned adult patients who presented to the emergency department with septic shock to receive either fluids at restricted volumes and early vasopressor therapy (vasopressor group) or higher volumes of fluids and later vasopressor therapy (fluids group) for at least 6 hours and up to 24 hours. The primary outcome was days alive and out of the hospital from randomization to day 90. RESULTS: A total of 1000 patients underwent randomization, with 499 assigned to the vasopressor group and 501 to the fluids group. Informed consent was not obtained for 37 patients, which left 963 patients in the intention-to-treat population (481 in the vasopressor group and 482 in the fluids group). Three patients in the fluids group were lost to follow-up for the primary outcome. In the first 24 hours after randomization, patients in the vasopressor group received less intravenous fluid than those in the fluids group (median difference, -1108 ml; 95% confidence interval [CI], -1395 to -850). The percentage of patients who received vasopressors was higher by 18.9 percentage points (95% CI, 13.3 to 24.5) in the vasopressor group. The median number of days alive and out of the hospital at day 90 was 76 (interquartile range, 55 to 83) in the vasopressor group and 76 (interquartile range, 55 to 82) in the fluids group (difference, 0.0 days; 95% CI, -2.7 to 2.7; P = 1.00). Adverse events occurred in similar percentages of patients in the two groups, except for pulmonary edema (0.6% in the vasopressor group vs. 5.0% in the fluids group; P<0.001). CONCLUSIONS: Among adult patients who presented to the emergency department with septic shock, an approach that involved restricted fluid volume and early vasopressors did not result in a greater number of days alive and out of the hospital at day 90 than an approach involving greater fluid volume and later administration of vasopressors. (Funded by the Australian National Health and Medical Council Medical Research Future Fund and the New Zealand Health Research Council; ARISE FLUIDS ClinicalTrials.gov number, NCT04569942.).