The Effect of Renastart Formula Supplementation on Serum Electrolytes in Children With Acute Kidney Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Month to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: 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.
Intervention: Renastart formula (Dietary Supplement)
Outcomes
Primary Outcomes
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.
Time Frame: monthly for 3 months
serum electrolytes
Secondary Outcomes
No secondary outcomes reported
Investigators
Haya Essam Ibrahim
lecturer of pediatrics
Ain Shams University