Importance It is not known if use of colloid solutions containing hydroxyethyl starch (HES) to correct for intravascular deficits in high-risk surgical patients is either effective or safe. Objective To evaluate the effect of HES 130/0.4 compared with 0.9% saline for intravascular volume expansion on mortality and postoperative complications after major abdominal surgery. Design, Setting, and Participants Multicenter, double-blind, parallel-group, randomized clinical trial of 775 adult patients at increased risk of postoperative kidney injury undergoing major abdominal surgery at 20 university hospitals in France from February 2016 to July 2018; final follow-up was in October 2018. Interventions Patients were randomized to receive fluid containing either 6% HES 130/0.4 diluted in 0.9% saline (n = 389) or 0.9% saline alone (n = 386) in 250-mL boluses using an individualized hemodynamic algorithm during surgery and for up to 24 hours on the first postoperative day, defined as ending at 7:59 am the following day. Main Outcomes and Measures The primary outcome was a composite of death or major postoperative complications at 14 days after surgery. Secondary outcomes included predefined postoperative complications within 14 days after surgery, durations of intensive care unit and hospital stays, and all-cause mortality at postoperative days 28 and 90. Results Among 826 patients enrolled (mean age, 68 [SD, 7] years; 91 women [12%]), 775 (94%) completed the trial. The primary outcome occurred in 139 of 389 patients (36%) in the HES group and 125 of 386 patients (32%) in the saline group (difference, 3.3% [95% CI, -3.3% to 10.0%]; relative risk, 1.10 [95% CI, 0.91-1.34]; P = .33). Among 12 prespecified secondary outcomes reported, 11 showed no significant difference, but a statistically significant difference was found in median volume of study fluid administered on day 1: 1250 mL (interquartile range, 750-2000 mL) in the HES group and 1500 mL (interquartile range, 750-2150 mL) in the saline group (median difference, 250 mL [95% CI, 83-417 mL]; P = .006). At 28 days after surgery, 4.1% and 2.3% of patients had died in the HES and saline groups, respectively (difference, 1.8% [95% CI, -0.7% to 4.3%]; relative risk, 1.76 [95% CI, 0.79-3.94]; P = .17). Conclusions and Relevance Among patients at risk of postoperative kidney injury undergoing major abdominal surgery, use of HES for volume replacement therapy compared with 0.9% saline resulted in no significant difference in a composite outcome of death or major postoperative complications within 14 days after surgery. These findings do not support the use of HES for volume replacement therapy in such patients. Trial Registration ClinicalTrials.gov Identifier: NCT02502773.

中文翻译：

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羟乙基淀粉与生理盐水容量替代治疗对接受大腹部手术的高危患者死亡或术后并发症的影响

重要性 目前尚不清楚使用含有羟乙基淀粉 (HES) 的胶体溶液来纠正高危手术患者的血管内缺陷是否有效或安全。目的 评价 HES 130/0.4 与 0.9% 生理盐水扩张血管内容量对腹部大手术后死亡率和术后并发症的影响。设计、设置和参与者 2016 年 2 月至 2018 年 7 月在法国 20 家大学医院接受腹部大手术的 775 名术后肾损伤风险增加的成年患者的多中心、双盲、平行组、随机临床试验；最终随访时间为 2018 年 10 月。 干预措施 患者随机接受含有 6% HES 130/0.4 稀释于 0.9% 生理盐水（n = 389）或 0 的液体。在手术期间和术后第一天（定义为在第二天上午 7:59 结束）使用个性化血流动力学算法在 250 mL 推注中单独使用 9% 生理盐水（n = 386）。主要结果和测量主要结果是术后 14 天死亡或主要术后并发症的复合。次要结果包括术后 14 天内预先确定的术后并发症、重症监护病房和住院时间以及术后第 28 天和第 90 天的全因死亡率。 结果 在纳入的 826 名患者中（平均年龄，68 [SD，7] 岁； 91 名女性 [12%])，775 名 (94%) 完成了试验。HES 组 389 名患者中的 139 名 (36%) 和生理盐水组 386 名患者中的 125 名 (32%) 出现主要结局（差异，3.3% [95% CI，-3.3% 至 10.0%]；相对风险） , 1.10 [95% CI, 0.91-1.34]；P = .33）。在报告的 12 项预先指定的次要结果中，11 项没有显示出显着差异，但在第 1 天给药的研究液体中位数方面发现了统计学上的显着差异：HES 组为 1250 mL（四分位距，750-2000 mL）和 1500 mL（生理盐水组的四分位距，750-2150 mL）（中位数差异，250 mL [95% CI，83-417 mL]；P = .006）。手术后 28 天，HES 和生理盐水组分别有 4.1% 和 2.3% 的患者死亡（差异，1.8% [95% CI，-0.7% 至 4.3%]；相对风险，1.76 [95% CI， 0.79-3.94]；P = .17）。结论和相关性 在接受腹部大手术的术后肾损伤风险患者中，使用 HES 进行容量替代治疗与 0. 9% 生理盐水导致术后 14 天内死亡或主要术后并发症的复合结果没有显着差异。这些发现不支持在此类患者中使用 HES 进行容量替代治疗。试验注册 ClinicalTrials.gov 标识符：NCT02502773。