The Effect of Renastart Formula Supplementation on Serum Electrolytes in Children With Acute Kidney Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness and tolerability of Renastart formula in children with AKI and acute on top of CKD to correct and maintain normal serum levels of electrolytes.
研究概览
简要总结
This clinical trial will evaluate Renastart formula effectiveness in children with acute kidney injury (AKI) and acute on top of chronic kidney disease (CKD), in maintaining normal serum electrolytes levels without using electrolyte binders,24 patients will be recruited from Pediatric Nephrology Unit (PNU), Children's Hospital, Ain Shams University, they will be assigned randomly in to two arms, arm 1 including patients who will be treated by electrolytes binders, arm 2 including patients who will be treated by Renastart formula, after initial assessment serum electrolyte evaluation will be followed up monthly for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants and Children with AKI and acute on top of CKD Suffering from hyperkalemia and/or hyperphosphatemia at Pediatric Nephrology Unit (PNU), Children's Hospital, Ain Shams University Hospitals.
排除标准
- •Patients are on dialysis.
- •Pediatric patients with coexisting another medical problems and different risk factors which can affect serum electrolytes such as: Constipation, high volume blood transfusion and Diabetes medications disrupt potassium balance e.g., ACEI, ARBS and Diuretics.
研究组 & 干预措施
Arm 1 patients with AKI and acute on top of CKD who will be treated by electrolytes binders.
they will start calcium carbonate (phosphorus binder) with dosage 45-65 mg/kg/day orally with / or sodium polystyrene sulfonate (potassium binder) with dosage 0.5-1mg/kg/day orally.
干预措施: calcium carbonate (phosphorus binder) with / or sodium polystyrene sulfonate (potassium binder) with dosage 0.5-1mg/kg/day orally. (Drug)
Arm 2 patients with AKI and acute on top of CKD who will be treated by Renastart formula.
- Renastart formula will be used with breast milk, standard infant formula or with diet.
- Preparation: Adding one level scoop of Renastart to 30 ml water.
- Renastart formula will be started to represent ¼ recommended daily allowance of daily caloric intake and the dose will be adjusted according to serum electrolyte levels.
干预措施: Renastart formula (Dietary Supplement)
结局指标
主要结局
To evaluate the effectiveness and tolerability of Renastart formula in children with AKI and acute on top of CKD to correct and maintain normal serum levels of electrolytes.
时间窗: monthly for 3 months
serum electrolytes
次要结局
未报告次要终点
研究者
Haya Essam Ibrahim
lecturer of pediatrics
Ain Shams University