Centre Hospitalier Universitaire (CHU) Clermont-Ferrand, Département Anesthésie et Réanimation, Hôpital Estaing, Université Clermont Auvergne, CNRS, Inserm U-1103, Clermont-Ferrand, France.
CHU de Lille, Pôle Anesthésie Réanimation, Hôpital Claude Huriez, Lille, France.
JAMA. 2020 Jan 21;323(3):225-236. doi: 10.1001/jama.2019.20833.
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.
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.
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.
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.
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).
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.
ClinicalTrials.gov Identifier: NCT02502773.
目前尚不清楚在高危外科手术患者中使用含有羟乙基淀粉（HES）的胶体溶液来纠正血管内缺陷是否有效或安全。
评估与 0.9%生理盐水相比，HES 130/0.4 用于纠正高危外科手术后患者的血管内容量扩张，对死亡率和术后并发症的影响。
设计、地点和参与者：多中心、双盲、平行组、随机临床试验，纳入了 20 所法国大学医院 775 名患有术后肾脏损伤风险增加的成年患者，这些患者接受了腹部大手术；从 2016 年 2 月至 2018 年 7 月入组，最终随访时间为 2018 年 10 月。
患者在手术期间和术后第 1 天的前 24 小时内（定义为次日上午 7:59 结束）使用个体化血流动力学算法接受含有 6% HES 130/0.4 的液体（n=389）或仅含有 0.9%生理盐水（n=386）的 250-mL 推注液。
主要结局是术后 14 天内死亡或主要术后并发症的复合结局。次要结局包括术后 14 天内的预定义术后并发症、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。
在纳入的 826 名患者（平均年龄 68[SD，7]岁；91 名女性[12%]）中，775 名（94%）完成了试验。HES 组 389 名患者中有 139 名（36%）和生理盐水组 386 名患者中有 125 名（32%）发生了主要结局（差异 3.3%[95%CI，-3.3%至 10.0%]；相对风险 1.10[95%CI，0.91-1.34]；P=0.33）。在报告的 12 个预先指定的次要结局中，11 个没有显著差异，但在第 1 天接受的研究液体的中位体积上有统计学差异：HES 组 1250 mL（四分位距，750-2000 mL）和生理盐水组 1500 mL（四分位距，750-2150 mL）（中位数差异 250 mL[95%CI，83-417 mL]；P=0.006）。术后第 28 天，HES 组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=0.17）。
在有术后肾脏损伤风险的接受腹部大手术的患者中，与 0.9%生理盐水相比，使用 HES 进行容量替代治疗在术后 14 天内的死亡或主要术后并发症复合结局方面没有显著差异。这些发现不支持在这类患者中使用 HES 进行容量替代治疗。
ClinicalTrials.gov 标识符：NCT02502773。
