Comparison of furosemide infusion alone with albumin-furosemide combination for the treatment of refractory edema in children with nephrotic syndrome: a randomized controlled non-inferiority trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To determine the mean difference in percentage weight loss at 24 hours in children with nephrotic syndrome and refractory edema receiving furosemide infusion in comparison to those receiving albumin-furosemide combination
研究概览
简要总结
This randomized controlled non-inferiority trial is aimed to demonstrate the noninferiority of furosemide infusion alone in comparison to albumin-furosemide combination in treatment of refractory edema in children with nephrotic syndrome. Children, between 1-12 years of age, with nephrotic syndrome and refractory edema (<1% weight loss per day for 5 consecutive days or <5% cumulative weight loss by 5th day of hospitalization after receiving maximum oral dose of furosemide, hydrochlorothiazide or metolazone and IV furosemide bolus in sequence) will be enrolled for the study. Primary objective of the study is to compare the percentage change in body weight after 24 hours of therapy in children with nephrotic syndrome having refractory edema receiving furosemide infusion alone with those receiving albumin-furosemide combination. Secondary objectives are- to compare urine output, urinary sodium excretion and hearing threshold at discharge between two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children, between 1-12 years of age, with nephrotic syndrome and refractory edema (<1% weight loss per day for 5 consecutive days or <5% cumulative weight loss by 5th day of hospitalization after receiving maximum oral dose of furosemide, hydrochlorothiazide or metolazone and IV furosemide bolus in sequence) will be enrolled for the study.
排除标准
- •1.Known secondary causes of nephrotic syndrome or with features of glomerulonephritis; like gross hematuria, hypertension, oliguria and deranged kidney function.
- •2.Children with acute diarrhoea 3.Clinical features of hypovolemia 4.With AKI stage II or III according to KDIGO definition and classification criteria for AKI 5.Children with severe systemic infections; like pneumonia, peritonitis, cellulitis or sepsis 6.Children with respiratory distress.
结局指标
主要结局
To determine the mean difference in percentage weight loss at 24 hours in children with nephrotic syndrome and refractory edema receiving furosemide infusion in comparison to those receiving albumin-furosemide combination
时间窗: 24 hours
次要结局
- 1.Mean difference in percentage weight loss between two groups.