Department of Pediatrics, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.
Pediatrics. 2011 Nov;128(5):857-66. doi: 10.1542/peds.2011-0415. Epub 2011 Oct 17.
The objective of this randomized controlled trial was to evaluate the risk of hyponatremia following administration of a isotonic (0.9% saline) compared to a hypotonic (0.45% saline) parenteral maintenance solution (PMS) for 48 hours to postoperative pediatric patients.
Surgical patients 6 months to 16 years of age with an expected postoperative stay of >24 hours were eligible. Patients with an uncorrected baseline plasma sodium level abnormality, hemodynamic instability, chronic diuretic use, previous enrollment, and those for whom either hypotonic PMS or isotonic PMS was considered contraindicated or necessary, were excluded. A fully blinded randomized controlled trial was performed. The primary outcome was acute hyponatremia. Secondary outcomes included severe hyponatremia, hypernatremia, adverse events attributable to acute plasma sodium level changes, and antidiuretic hormone levels.
A total of 258 patients were enrolled and assigned randomly to receive hypotonic PMS (N = 130) or isotonic PMS (N = 128). Baseline characteristics were similar for the 2 groups. Hypotonic PMS significantly increased the risk of hyponatremia, compared with isotonic PMS (40.8% vs 22.7%; relative risk: 1.82 [95% confidence interval: 1.21-2.74]; P = .004). Admission to the pediatric critical care unit was not an independent risk factor for the development of hyponatremia. Isotonic PMS did not increase the risk of hypernatremia (relative risk: 1.30 [95% confidence interval: 0.30-5.59]; P = .722). Antidiuretic hormone levels and adverse events were not significantly different between the groups.
Isotonic PMS is significantly safer than hypotonic PMS in protecting against acute postoperative hyponatremia in children.
本随机对照试验的目的是评估术后儿童患者接受等渗（0.9%盐水）与低渗（0.45%盐水）肠外维持液（PMS）治疗 48 小时后发生低钠血症的风险。
年龄在 6 个月至 16 岁之间，预计术后住院时间>24 小时的手术患者符合入选条件。有未纠正的基础血浆钠水平异常、血流动力学不稳定、慢性利尿剂使用、先前入组以及低渗 PMS 或等渗 PMS 被认为禁忌或必需的患者被排除在外。进行了一项完全盲法随机对照试验。主要结局为急性低钠血症。次要结局包括严重低钠血症、高钠血症、急性血浆钠水平变化相关的不良事件和抗利尿激素水平。
共纳入 258 例患者并随机分为接受低渗 PMS（N=130）或等渗 PMS（N=128）治疗。两组的基线特征相似。与等渗 PMS 相比，低渗 PMS 显著增加了低钠血症的风险（40.8%比 22.7%；相对风险：1.82[95%置信区间：1.21-2.74]；P=0.004）。入住儿科重症监护病房不是低钠血症发生的独立危险因素。等渗 PMS 并未增加高钠血症的风险（相对风险：1.30[95%置信区间：0.30-5.59]；P=0.722）。两组抗利尿激素水平和不良事件无显著差异。
与低渗 PMS 相比，等渗 PMS 可显著降低儿童术后急性低钠血症的风险。
