Maintenance Intravenous Fluids in Children
Condition: Hyponatremia
MeSH terms: Hyponatremia
Intervention: Isotonic fluid; Hypotonic fluid; Hypotonic fluid
Intervention description: 0.9% saline with 5% dextrose at standard maintenance rate; Reduced volume (two thirds of standard maintenance rate) of N/5 saline in 5% dextrose; N/5 saline in 5% dextrose at standard maintenance rate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 167.0
Sex: All
Minimum age: 3 Months
Maximum age: 12 Years
Healthy volunteers: No
Keywords: maintenance fluids; hyponatremia; vasopressin; children

Summary:

      Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important
      reason for this high incidence could be use of hypotonic fluids in sick children for
      maintenance fluid therapy. There are no randomized controlled trials to evaluate the effect
      of various types of intravenous fluids on the incidence of hyponatremia in sick hospitalized
      children.

      Hypothesis: Use of normal saline in 5% dextrose or reduced (2/3) volume of N/5 saline in 5%
      dextrose reduces incidence of hyponatremia (serum sodium 130 mmol/L) by two-thirds when
      compared to N/5 saline in 5% dextrose at standard maintenance rate in hospitalized children
      receiving intravenous maintenance fluids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All children (3 months to 12 years) who are admitted to pediatric ward or pediatric
             ICU, who require exclusive intravenous maintenance fluid therapy for at least 24 hours
             will be eligible for the study

        Exclusion Criteria:

          -  Children with illness that have primary fluid and electrolyte imbalance such as:

               -  Shock: Defined as acute circulatory failure resulting in decreased tissue
                  perfusion and manifesting as altered sensorium, hypothermia (<35oC), tachycardia,
                  prolonged capillary filling time (>3 seconds), hypotension (BP < 5th percentile
                  for age), oliguria (<0.5 ml/kg/hr), hypoxemia, hyperlactatemia, requirement of
                  fluid bolus and/ or vasopressors.

               -  Diarrhea and Dehydration: Children presenting with diarrhea and features of
                  dehydration: lethargy, irritability and altered sensorium, thirst, decreased
                  urine output, sunken eyes & dry mucous membranes, loss of skin elasticity.;
                  children with ongoing diarrhea will be excluded even if there is no dehydration.

               -  Fluid Overload: Cirrhosis, Congestive heart failure, Acute and Chronic renal
                  failure, Nephrotic syndrome.

          -  Abnormal serum sodium or Hyperglycemia at Presentation:

               -  Hyponatremia : serum sodium < 130 mmol/L.

               -  Hypernatremia : serum sodium >150 mmol/L.

               -  Hyperglycemia: blood glucose > 180 mg/ dl.

          -  Severe Protein Energy Malnutrition: Defined as grade III (50-59% of expected weight
             for age) and grade IV (less than 50% of expected weight for age) as per IAP
             classification.

          -  Child who is receiving drugs which cause abnormality in serum sodium such as
             diuretics, vasopressin, etc.