Efficacy and safety of recommended dose of albumin infusion vs. low dose albumin infusion in patients of decompensated cirrhosis with Acute Kidney Injury
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The proportion of decompensated cirrhosis patients having acute kidney injury with complete resolution
研究概览
简要总结
Ours is a Open labelled Randomized controlled trial in which we aim to compare the efficacy and safety of 20% human albumin infusion at a dose of 1gm/kg body weight daily (maximum dose 100gm) with albumin infusion at a dose of 0.5 gm/kg body weight (maximum dose 40gm) in patients with decompensated cirrhosis having acute kidney injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed cases of decompensated cirrhosis with Acute kidney injury ≥Stage IB i.e. Serum creatinine ≥1.5mg/dl.
排除标准
- •Pregnancy Advanced Chronic Kidney Disease Shock Prior Kidney or Liver Transplant Acute or chronic Renal Replacement Therapy at the time of enrolment Congestive heart failure ï‚· Known allergy or develops allergic reaction to human albumin.
结局指标
主要结局
The proportion of decompensated cirrhosis patients having acute kidney injury with complete resolution
时间窗: After 2 consecutive days of fluid challenge with 20% human albumin at a dose of – | 1gm/kg of body weight daily | 0.5gm/kg of body weight daily
(S. Cr. within 0.3mg/dl of Baseline S. Creatinine) of acute kidney injury after 2 consecutive days of fluid
时间窗: After 2 consecutive days of fluid challenge with 20% human albumin at a dose of – | 1gm/kg of body weight daily | 0.5gm/kg of body weight daily
challenge with 20% human albumin at a dose of –
时间窗: After 2 consecutive days of fluid challenge with 20% human albumin at a dose of – | 1gm/kg of body weight daily | 0.5gm/kg of body weight daily
1gm/kg of body weight daily;
时间窗: After 2 consecutive days of fluid challenge with 20% human albumin at a dose of – | 1gm/kg of body weight daily | 0.5gm/kg of body weight daily
0.5gm/kg of body weight daily
时间窗: After 2 consecutive days of fluid challenge with 20% human albumin at a dose of – | 1gm/kg of body weight daily | 0.5gm/kg of body weight daily
次要结局
- Frequency of adverse events among patients treated with 20% human albumin at a dose of-(1gm/kg of body weight daily;)
研究者
Dr Aman Agrawal
Delhi University