CTRI/2025/09/095042尚未招募不适用
Efficacy and safety of tolvaptan in oral furosemide refractory edema in Nephrotic Syndrome : a prospective interventional trial
APC PGIMER1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年9月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Urine output over 48 hours (ml/kg/hr) after adding Tolvaptan
研究概览
简要总结
In children 5-14 years of age diagnosed with nephrotic syndrome, having moderate to severe oedema, fulfilling the inclusions and exclusion criteria will be enrolled in the study. All the participants will be given 2-4mg/kg/day of furosemide. The children who have weight loss <3% of baseline body weight after 24 hours of oral furosemide will be considered furosemide refractory. In these children tolvaptan will be added with furosemide for next 48 hours. Children will be evaluated for urine output and percentage weight loss over 48 hours after adding tolvaptan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •children with nephrotic syndrome with moderate to severe oedema.
排除标准
- •Hypovolemia, CSVT, sodium less than 125 or more than 140, eGFR less than 60, SGOT and SGPT more than 2 times upper normal limit, other diuretics.
结局指标
主要结局
Urine output over 48 hours (ml/kg/hr) after adding Tolvaptan
时间窗: 48 hours after intervention
次要结局
- Percentage weight loss over the first 48 hours of combination therapy(48 hours)
- Urine and serum osmolality before and every 24 hours of therapy(48 hours)
- Serum copeptin levels before and after the tolvaptan therapy(48 hours)
研究者
Shailza Mahajan
PGIMER
研究点 (1)
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