Plasmalyte-A versus Normal saline for fluid replacement therapy in Dengue in children: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in plasma bicarbonate level
Study Overview
Brief Summary
This randomized controlled trial is designed to compare, in hospital setting, two isotonic fluids, i.e. Plasmalyte-A and normal saline for fluid replacement in children with Dengue requiring IV fluid therapy. Fluid shall be administered as per the WHO treatment guidelines for fluid replacement in children with dengue. The primary outcome measure of the study is change in plasma bicarbonate level at 6 hours from baseline. Secondary outcome measures include total volume of fluid received, fluid rate, urine output, proportion of patients with fluid overload, serum levels of sodium, potassium, urea, creatinine, glucose, hematocrit level, modified Glasgow Coma Score and in-hospital mortality.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 0.00 Year(s) to 14.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Diagnosed cases of dengue based on clinical features and laboratory reports (including Dengue IgM,IgG and NS1 levels) requiring intravenous fluid therapy.
Exclusion Criteria
- •(1)Comorbid conditions that may affect the outcome of the study like chronic liver disease, congenital heart disease, etc (2) Allergies to Normal saline (0.9%) or Plasmalyte-A (3)Patients with PeLOD-2 score of more than or equal to 14 (4) Refusal to participate in the study.
Outcomes
Primary Outcomes
Change in plasma bicarbonate level
Time Frame: At enrollment and after 6 hours of administration of replacement fluid
Secondary Outcomes
- Total volume of fluid received, Fluid rate, urine output and proportion with fluid overload(6 hours)
- Serum electrolytes (Na, K, Ca), urea, creatinine, glucose and haematocrit level(0 hours and 6 hours)
- Glasgow coma scale(6 hours)
- Duration of hospital stay and in-hospital mortality(till discharge or in-hospital mortality)
Investigators
KAMRAN AFZAL
Department of Pediatrics, Jawaharlal Nehru Medical College , AMU, Aligarh