NEJM：脓毒症患者ICU输液的限制

BACKGROUND

Intravenous fluids are recommended for the treatment of patients who are in sep- tic shock, but higher fluid volumes have been associated with harm in patients who are in the intensive care unit (ICU).

静脉输液被推荐用于治疗脓毒性休克患者，但在重症监护室(ICU)中，较高的液体容量会对患者造成危害。

METHODS

In this international, randomized trial, we assigned patients with septic shock in the ICU who had received at least 1 liter of intravenous fluid to receive restricted intravenous fluid or standard intravenous fluid therapy; patients were included if the onset of shock had been within 12 hours before screening. The primary out- come was death from any cause within 90 days after randomization.

在这项国际、随机试验中，我们将ICU中至少接受1L静脉输液的脓毒性休克患者分配至接受限制性静脉输液或标准静脉输液治疗；如果休克发生在筛选前12小时内，则纳入患者。主要结果是随机分组后90天全因死亡率。

RESULTS

We enrolled 1554 patients; 770 were assigned to the restrictive-fluid group and 784 to the standard-fluid group. Primary outcome data were available for 1545 patients (99.4%). In the ICU, the restrictive-fluid group received a median of 1798 ml of in- travenous fluid (interquartile range, 500 to 4366); the standard-fluid group received a median of 3811 ml (interquartile range, 1861 to 6762). At 90 days, death had occurred in 323 of 764 patients (42.3%) in the restrictive-fluid group, as compared with 329 of 781 patients (42.1%) in the standard-fluid group (adjusted absolute difference, 0.1 percentage points; 95% confidence interval [CI], −4.7 to 4.9; P=0.96). In the ICU, serious adverse events occurred at least once in 221 of 751 patients (29.4%) in the restrictive-fluid group and in 238 of 772 patients (30.8%) in the standard-fluid group (adjusted absolute difference, −1.7 percentage points; 99% CI, −7.7 to 4.3). At 90 days after randomization, the numbers of days alive without life support and days alive and out of the hospital were similar in the two groups.

我们招募了1554名患者；770人被分配到限制性液体组，784人被分配到标准液体组。1545名患者（99.4%）获得了主要结果数据。在ICU，限制性液体组接受的静脉内液体中位数为1798毫升（四分位间距为500至4366）；标准液体组的中位数为3811毫升（四分位间距1861至6762）。90天时，限制性液体组764名患者中有323名患者（42.3%）死亡，而标准液体组781名患者中有329名患者（42.1%）死亡（调整后的绝对差异为0.1个百分点；95%可信区间[CI]，−4.7至4.9；P=0.96）。在ICU，限制性液体组751名患者中有221名（29.4%）发生严重不良事件，标准液体组772名患者中有238名（30.8%）发生严重不良事件（调整后的绝对差异，−1.7个百分点；99%置信区间，−7.7至4.3）。随机分组后90天，两组无生命支持的存活天数、存活天数和出院天数相似。

CONCLUSIONS

Among adult patients with septic shock in the ICU, intravenous fluid restriction did not result in fewer deaths at 90 days than standard intravenous fluid therapy. (Funded by the Novo Nordisk Foundation and others; CLASSIC ClinicalTrials.gov number, NCT03668236.)

在ICU感染性休克的成年患者中，与标准静脉输液治疗相比，静脉输液限制在90天内不会导致更少的死亡。