Vasopressors or Fluids in Early Septic Shock.

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.

在使用较大剂量静脉输液以恢复灌注和早期使用血管加压药物治疗以及使用较小剂量液体以最小化过多液体潜在危害之间存在平衡。

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.

我们随机分配了来到急诊科的成年脓毒性休克患者，接受限制性液体量和早期血管加压治疗（血管加压组）或较高剂量液体和后期血管加压治疗（液体组），持续至少6小时，最多24小时。

The primary outcome was days alive and out of the hospital from randomization to day 90.

主要结果是从随机分组到第90天的存活天数且未住院。

Results

A total of 1000 patients underwent randomization, with 499 assigned to the vasopressor group and 501 to the fluids group.

共有1000名患者进行了随机分组，其中499名被分配到血管加压组，501名被分配到液体组。

Informed consent was not obtained for 37 patients, which left 963 patients in the intention-to-treatpopulation (481 in the vasopressor group and 482 in the fluids group).

未获得37名患者的知情同意，这使得意向治疗人群中有963名患者（血管加压组481名，液体组482名）。

Three patients in the fluids group were lost to follow-up for the primary outcome.

液体组有3名患者在主要结果的随访中失访。

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).

在随机分组后的前24小时内，血管加压组患者接受的静脉输液量少于液体组患者（中位数差异，-1108毫升；95%置信区间[CI]，-1395至-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.

在使用血管加压药物的组别中，接受血管加压药物治疗的患者比例比对照组高出18.9个百分点（95%置信区间，13.3至24.5）。

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).

在第90天时，使用血管加压药物的组别中，存活并出院的中位天数为76天（四分位数间距，55至83天），而液体治疗组为76天（四分位数间距，55至82天）（差异，0.0天；95%置信区间，-2.7至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).

两组患者中不良事件的发生比例相似，除了肺水肿的发生率（血管加压药物组为0.6%，液体治疗组为5.0%；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.

在出现败血性休克的成年急诊患者中，一种涉及限制液体量和早期使用血管加压药物的方法，并没有比涉及更大液体量和后期使用血管加压药物的方法在第90天时有更多的存活并出院的天数。

(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.).

(该研究由澳大利亚国家卫生和医学研究委员会医学研究未来基金以及新西兰卫生研究委员会资助；ARISE FLUIDS ClinicalTrials.gov编号，NCT04569942。)