Clinical Trial of Fluid Infusion Rates for Pediatric Diabetic Ketoacidosis.
Clinical Trial of Fluid Infusion Rates for Pediatric Diabetic Ketoacidosis.
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DOI：
10.1056/nejmoa1716816
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发表时间：
2018-06-14
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影响因子：
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通讯作者：
PECARN DKA FLUID Study Group
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作者：
Kuppermann N;Ghetti S;Schunk JE;Stoner MJ;Rewers A;McManemy JK;Myers SR;Nigrovic LE;Garro A;Brown KM;Quayle KS;Trainor JL;Tzimenatos L;Bennett JE;DePiero AD;Kwok MY;Perry CS 3rd;Olsen CS;Casper TC;Dean JM;Glaser NS;PECARN DKA FLUID Study Group
儿童糖尿病酮症酸中毒可引起轻度至重度脑损伤。静脉输液是否会导致这些损伤已经争论了几十年。我们进行了一项13个中心的随机对照试验，检查了给药速率和静脉输液氯化钠含量对糖尿病酮症酸中毒儿童神经功能结局的影响。在2 × 2析因设计中，儿童被随机分配到四个治疗组中的一个（0.9%或0.45%氯化钠含量和快速或慢速给药）。主要结局是糖尿病酮症酸中毒治疗期间精神状态下降（连续两次格拉斯哥昏迷量表评分<14，范围为3 - 15，评分越低表明精神状态越差）。次要结局包括糖尿病酮症酸中毒治疗期间的临床明显脑损伤、糖尿病酮症酸中毒治疗期间的短期记忆以及糖尿病酮症酸中毒恢复后2 - 6个月的记忆和智商。在1255名儿童中共报告了1389例糖尿病酮症酸中毒事件。格拉斯哥昏迷量表评分在48次（3.5%）中降至14分以下，12次（0.9%）发生临床明显脑损伤。在格拉斯哥昏迷量表评分降至14分以下的发作百分比、格拉斯哥昏迷量表评分的下降幅度或格拉斯哥昏迷量表评分低于14分的持续时间方面，未观察到治疗组之间的显著差异;或关于糖尿病酮症酸中毒治疗期间临床上明显脑损伤的发生率。儿童从糖尿病酮症酸中毒中恢复后获得的记忆力和智商分数在各组之间也没有显著差异。除精神状态改变以外的严重不良事件罕见，并且在所有治疗组中的发生频率相似。无论是给药速度还是静脉输液的氯化钠含量都不会显著影响糖尿病酮症酸中毒儿童的神经功能结局。（由Eunice Kennedy Shriver国家儿童健康和人类发展研究所以及卫生资源和服务管理局资助; PECARN DKA FLUID ClinicalTrials.gov编号，NCT 00629707。
Diabetic ketoacidosis in children may cause brain injuries ranging from mild to severe. Whether intravenous fluids contribute to these injuries has been debated for decades. We conducted a 13-center, randomized, controlled trial that examined the effects of the rate of administration and the sodium chloride content of intravenous fluids on neurologic outcomes in children with diabetic ketoacidosis. Children were randomly assigned to one of four treatment groups in a 2-by-2 factorial design (0.9% or 0.45% sodium chloride content and rapid or slow rate of administration). The primary outcome was a decline in mental status (two consecutive Glasgow Coma Scale scores of <14, on a scale ranging from 3 to 15, with lower scores indicating worse mental status) during treatment for diabetic ketoacidosis. Secondary outcomes included clinically apparent brain injury during treatment for diabetic ketoacidosis, short-term memory during treatment for diabetic ketoacidosis, and memory and IQ 2 to 6 months after recovery from diabetic ketoacidosis. A total of 1389 episodes of diabetic ketoacidosis were reported in 1255 children. The Glasgow Coma Scale score declined to less than 14 in 48 episodes (3.5%), and clinically apparent brain injury occurred in 12 episodes (0.9%). No significant differences among the treatment groups were observed with respect to the percentage of episodes in which the Glasgow Coma Scale score declined to below 14, the magnitude of decline in the Glasgow Coma Scale score, or the duration of time in which the Glasgow Coma Scale score was less than 14; with respect to the results of the tests of short-term memory; or with respect to the incidence of clinically apparent brain injury during treatment for diabetic ketoacidosis. Memory and IQ scores obtained after the children’s recovery from diabetic ketoacidosis also did not differ significantly among the groups. Serious adverse events other than altered mental status were rare and occurred with similar frequency in all treatment groups. Neither the rate of administration nor the sodium chloride content of intravenous fluids significantly influenced neurologic outcomes in children with diabetic ketoacidosis. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Health Resources and Services Administration; PECARN DKA FLUID ClinicalTrials.gov number, NCT00629707.)