Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children
Condition: Hyponatremia
MeSH terms: Hyponatremia
Intervention: 0.45% NaCl/dextrose 5%; 0.3% NaCl/dextrose 5%
Intervention description: Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m^2 body surface.; Drug: 0.3% NaCl/dextrose 5% IV maintenance fluids. Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m^2 surface.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 78.0
Sex: All
Minimum age: 1 Month
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Hyponatremia; Water-Electrolyte Imbalance

Summary:

      The primary objective of this study is to compare the blood sodium level after 12 hours
      following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose
      5%, in postsurgical hospitalized children requiring maintenance IV fluid administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postsurgical children admitted to HGNPE Department of Surgery between january 2010 and
             october 2011.

        Aged 1 month to 16 years. Initial plasma Na between 135-145 mmol/L. Primary route of fluid
        administration is anticipated to be intravenous, in the first 12 hours following surgery.

        Informed consent of parent/guardian.

        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.

                    -  Hyperglycemia: blood glucose > 180 mg/ dl.

                    -  Require ICU admission.

                    -  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.

                    -  Patients in whom either hypotonic or isotonic solutions may be
                       contraindicated/necessary: i.e. specific neurosurgical patients (ie those at
                       risk of increased ICP, e.g. requiring actual brain surgery, ICP monitor or
                       external ventricular drain insertion), patients with diabetic ketoacidosis,
                       acute (≤ 7 days) burns, pre-existing CHF, liver failure or cirrhosis, renal
                       failure.

                    -  Patients with known pre-existing risk of PNa derangements: DI or SIADH