Renal Morbidity of 6% Hydroxyethyl Starch 130/0.4 in 9000 Propensity Score Matched Pairs of Surgical Patients
Renal Morbidity of 6% Hydroxyethyl Starch 130/0.4 in 9000 Propensity Score Matched Pairs of Surgical Patients
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DOI：
10.1213/ane.0000000000004592
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发表时间：
2020-06-01
影响因子：
5.7
通讯作者：
Kotake, Yoshifumi
中科院分区：
文献类型：
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作者：
Miyao, Hideki;Kotake, Yoshifumi
背景：几项针对危重患者的研究报告称，羟乙基淀粉（HES）溶液的液体复苏会损害肾脏，但其在外科患者中的应用存在争议。由于不同的羟乙基淀粉制剂具有不同的安全性，我们试图确定6%的第三代羟乙基淀粉130/0.4是否与肾脏发病率相关，当用于手术患者时，方法：我们确定了在2014年至2016年期间接受手术的日本全国医疗数据库中登记的成年人，使用羟乙基淀粉130/0.4或不使用羟乙基淀粉（对照）。这些组以1：1的比例与倾向评分匹配，未通过包含36个协变量（包括人口统计学特征、术前合并症和麻醉/外科手术）的多变量logistic回归进行替换。主要结局是接受术中HES的患者和对照组的急性肾损伤（阿基）发生率。次要结局是评估HES是否与阿基分期恶化、肾脏替代治疗（RRT）的发生率、住院时间和住院30天死亡率相关。三级结局包括血管活性药物的使用和手术当天的液体需求。比较分析采用卡方检验、Mann-Whitney U检验或有序逻辑回归分析。结果：在数据库中的76，048例患者中，58，425例合格：9542例接受HES治疗，48，883例对照。倾向分数匹配确定了8823个匹配对。HES组阿基的发生率为6.2%（548/8823），对照组为5.6%（492/8823）（比值比[OR]，1.12; 95%置信区间[CI]，0.99-1.27; P = 0.07）。与对照组相比，HES与阿基分期恶化无关（OR，0.89; 95% CI，0.79-1.01; P = 0.08）。HES组RRT的发生率低于对照组（分别为0.2% vs 0.4%; OR，0.51; 95% CI，0.29-0.91; P = 0.02）。HES组的中位[四分位距]住院时间长1天（12 [8-21] vs 11 [7-20]天; P < .001），但两组的住院30天死亡率无差异（分别为0.5% vs 0.6%：OR，0.83; 95% CI，0.56-1.24; P = .36）。与对照组相比，羟乙基淀粉组的血管活性药物使用率和手术当天的中位净液体需求量较高（分别为80.5% vs 70.0%：P <0.001，88.1 vs 73.6 mL/kg; P <0.001）。结论：本研究并未证明6%羟乙基淀粉130/0.4会增加术后阿基的发生率和严重程度。当用于手术患者时，它与RRT的发生率较低相关。
BACKGROUND:Several studies of critically ill patients reported that fluid resuscitation with hydroxyethyl starch (HES) solutions damages the kidneys, but their use for surgical patients is debated. Because different HES preparations have different safety profiles, we sought to determine whether 6% third-generation HES 130/0.4 was associated with renal morbidity when used for surgical patients.METHODS:We identified adults enrolled in a Japanese nationwide medical database who underwent surgery between 2014 and 2016, with HES 130/0.4 or without it (controls). These groups were balanced with propensity score matching in a 1:1 ratio without replacement by multivariable logistic regression with 36 covariates, including demographic characteristics, preoperative comorbidities, and anesthetic/surgical procedures. The primary outcome was the incidence of acute kidney injury (AKI) in patients receiving intraoperative HES and controls. Secondary outcomes were assessing whether HES was associated with worsening AKI stage, the incidence of renal-replacement therapy (RRT), hospital length-of-stay, and in-hospital 30-day mortality. Tertiary outcomes include the use of vasoactive agents and the fluid requirement on the day of surgery. Comparative analysis was made with chi(2), Mann-Whitney U test, or the ordinal logistic regression analysis.RESULTS:Of 76,048 patients in the database, 58,425 were eligible: 9542 received HES and 48,883 controls. Propensity score matching identified 8823 matched pairs. The incidence of AKI was 6.2% (548/8823) in the HES group and 5.6% (492/8823) in controls (odds ratio [OR], 1.12; 95% confidence interval [CI], 0.99-1.27; P = .07). Compared to controls, HES was not associated with worsening AKI stage (OR, 0.89; 95% CI, 0.79-1.01; P = .08). The incidence of RRT was lower in the HES group than that in controls (0.2% vs 0.4%, respectively; OR, 0.51; 95% CI, 0.29-0.91; P = .02). Median [interquartile range] hospital stay was 1 day longer in the HES group (12 [8-21] vs 11 [7-20] days; P < .001), but in-hospital 30-day mortality did not differ between groups (0.5% vs 0.6%, respectively: OR, 0.83; 95% CI, 0.56-1.24; P = .36). The use rate of vasoactive agents and the median net fluid requirement on the day of surgery were higher in the HES group (80.5% vs 70.0%: P < .001, 88.1 vs 73.6 mL/kg; P < .001, respectively) compared to controls.CONCLUSIONS:The present study did not demonstrate that 6% HES 130/0.4 increased the incidence and the severity of postoperative AKI. It was associated with a lower incidence of RRT when used for surgical patients.