Maintenance Intravenous Fluids in Children
Condition: Hyponatremia
MeSH terms: Hyponatremia
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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. We therefore plan to conduct a randomized controlled trial to evaluate the effect
      of normal saline in 5% dextrose at standard maintenance rate, reduced volume (2/3 maintenance
      rate) of N/5 saline in 5% dextrose and N/5 saline in 5% dextrose at standard maintenance rate
      on the incidence of hyponatremia in hospitalized children, aged 3 months- 12 years. To
      determine serial plasma vasopressin levels in hospitalized children at baseline, 24 hours and
      48 hours of intravenous fluid therapy and compare the values in the three fluid regimens.

      Study design: Randomized controlled trial. Hospitalized children who fulfill inclusion
      criteria and not having any of the exclusion criteria will be considered for the enrolment
      after written informed consent. Venous blood samples will be taken at enrollment for
      estimation of serum sodium, potassium, chloride, bicarbonate, blood gas, blood sugar, blood
      urea, serum creatinine, and plasma osmolality. A sample for estimation of plasma vasopressin
      will be collected at baseline. After randomization into three groups, one group of children
      will receive N/5 saline in 5% dextrose at standard maintenance rate (100 ml/kg for the first
      10 kg of body weight, 50 ml/kg for the next 10 kg, and 20 ml/kg for body weight exceeding 20
      kg).The second group of children will receive N/5 saline in 5% dextrose at 2/3 maintenance
      rate. The third group will receive dextrose normal saline at standard maintenance rate. Serum
      Na+, K+ and urine Na+, K+ will be estimated every 12 hourly till the patient is on
      intravenous fluid therapy and 12 hrs after stopping exclusive intravenous maintenance fluids.
      Serum and urine osmolality will be estimated every 24 hrs by an osmometer. Plasma vasopressin
      will be estimated in children in the 3 groups at 24, and 48 hours of intravenous fluid
      therapy.

      Children will be weighed every 24 hours. The fluid balance, sodium balance, free water
      clearance will be calculated in a subset of children.

      The study measurements will be carried out only till the time the child is on exclusive
      intravenous maintenance fluid therapy or 72 hrs of starting the intravenous fluid therapy.
      The decision to decrease/ stop intravenous fluid therapy will be left to the treating unit.

      The primary outcome measure will be incidence of hyponatremia (defined as serum Na+ less than
      130 mmol/L).

      The secondary outcomes studied will be Plasma vasopressin levels at 24 hr and 48 hours and
      incidence of hypernatremia.

      Sample size: Based on literature review, the incidence of hyponatremia with standard
      intravenous fluid therapy is approximately 30%. Sample of 72 patients will be needed in each
      group to demonstrate the decrease in incidence of hyponatremia to 10%, with a beta of 0.2
      (Power 80%) and alpha error of 0.05.

      Analysis: The data will be analyzed using STATA software. The outcomes (primary and
      secondary) in the 3 groups will be compared. For continuous variables, t test or Wilcoxon
      rank-sum test will be used to determine statistical significance. For categorical variables,
      chi square test will be used.
    

Intervention name(s): Isotonic fluid; Hypotonic fluid; Hypotonic fluid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): Dextrose normal saline; Hypotonic fluid,; 0.2 % saline in 5 % dextrose; 0.2 % saline in 5% dextrose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: maintenance fluids; hyponatremia; vasopressin; children