Division of Pediatric Critical Care, Department of Pediatrics, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605 006, India.
Department of Biochemistry, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
Indian J Pediatr. 2021 Nov;88(11):1099-1106. doi: 10.1007/s12098-021-03727-3. Epub 2021 Apr 2.
To study whether furosemide infusion in early-onset acute kidney injury (AKI) in critically ill children would be associated with a reduced proportion of patients progressing to the higher stage (Injury or Failure) as compared to placebo.
A double-blind, placebo-controlled, randomized pilot trial was conducted. The authors enrolled children aged 1-mo (corrected) to 12-y, who were diagnosed with AKI ("risk" stage) using pediatric-Risk, Injury, Failure, Loss, End stage kidney disease (p-RIFLE) criteria, and achieved immediate resuscitation goals within 24 h of admission. Participants received either furosemide (0.05 to 0.4 mg/kg/h) or placebo (5%-dextrose) infusion. The primary outcome was the proportion of patients progressing to a higher stage (injury or failure). Secondary outcomes were (i) need for renal replacement therapy, (ii) the effect on neutrophil gelatinase-associated lipocalin (urine and blood), (iii) fluid balance, (iv) adverse effects, (v) time to achieve renal recovery, (vi) duration of hospital stay and mechanical ventilation, and (vii) all-cause 28-d mortality.
The trial was stopped for futility, and data were analyzed on an intention-to-treat basis (furosemide-group: n = 38; placebo-group: n = 37). No significant difference was noted in the progression of AKI to a higher stage between furosemide and placebo groups (10.5% vs. 21.6%; relative risk = 0.49, 95% CI 0.16 to 1.48) (p = 0.22). There were no differences in the secondary outcomes between the study groups. All-cause 28-d mortality was similar between the groups (10.5% vs. 10.8%). No trial-related severe adverse events occurred.
Furosemide infusion in early-onset AKI did not reduce the progression to a higher stage of AKI. A future trial with large sample size is warranted.
研究在危重症儿童中，早期急性肾损伤（AKI）中速尿的输注是否与相比安慰剂，患者进展为更高阶段（损伤或衰竭）的比例降低有关。
进行了一项双盲、安慰剂对照、随机的初步试验。研究人员纳入了年龄在 1 个月（矫正）至 12 岁的 AKI 患儿（“风险”期），使用儿科风险、损伤、衰竭、丧失、终末期肾病（p-RIFLE）标准诊断 AKI，且在入院后 24 小时内达到即刻复苏目标。患者接受速尿（0.05 至 0.4mg/kg/h）或安慰剂（5%-葡萄糖）输注。主要结局为进展为更高阶段（损伤或衰竭）的患者比例。次要结局为：（i）需要肾脏替代治疗，（ii）对中性粒细胞明胶酶相关脂质运载蛋白（尿液和血液）的影响，（iii）液体平衡，（iv）不良事件，（v）达到肾脏恢复的时间，（vi）住院时间和机械通气时间，以及（vii）全因 28 天死亡率。
试验因无效而停止，数据按意向治疗进行分析（速尿组：n=38；安慰剂组：n=37）。速尿组和安慰剂组的 AKI 进展为更高阶段无显著差异（10.5%比 21.6%；相对风险=0.49，95%CI 0.16 至 1.48）（p=0.22）。两组的次要结局无差异。两组的全因 28 天死亡率相似（10.5%比 10.8%）。未发生与试验相关的严重不良事件。
在早期 AKI 中速尿输注并未降低 AKI 进展为更高阶段的比例。需要更大样本量的未来试验来验证。
