Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

• rate of change in serum sodium
• hypertension
• congestive heart failure

• hypertension [ Time Frame: 8 to 20 hours ] [ Designated as safety issue: Yes ]
• congestive heart failure [ Time Frame: 8 to 20 hours ] [ Designated as safety issue: Yes ]

Hyponatremia associated with administration of hypotonic intravenous (IV) fluids may have serious complications. It has recently been suggested that isotonic saline may be a more appropriate choice of maintenance IV fluid. This pilot and feasibility study aims to compare isotonic saline to 0.45% saline in hospitalized children requiring parenteral fluid support in order to:

Aim 1: To determine the feasibility of conducting a double-blind, randomized controlled trial comparing these solutions.

Aim 2a: To compare the rate of change in serum Na (mmol/L/hr) and the incidence of hyponatremia (Na <136 mmol/L) between patients receiving isotonic and hypotonic intravenous fluids at at least 50% of the traditional maintenance rate for an interval of at least 8 hours.

Aim 2b: To compare the incidence of adverse events between the two IV fluid treatment groups.

• Gastroenteritis
• Bronchiolitis
• Sepsis
• Urinary Tract Infection

• Drug: 0.9% saline in 5% dextrose (intravenous)
  Other Name: isotonic saline
• Drug: 0.45% saline in 5% dextrose (intravenous)

• Experimental: A
  0.9% saline in 5% dextrose (intravenous)
  Intervention: Drug: 0.9% saline in 5% dextrose (intravenous)
• Active Comparator: B
  0.45% saline in 5% dextrose (intravenous)
  Intervention: Drug: 0.45% saline in 5% dextrose (intravenous)

• Hoorn EJ, Geary D, Robb M, Halperin ML, Bohn D. Acute hyponatremia related to intravenous fluid administration in hospitalized children: an observational study. Pediatrics. 2004 May;113(5):1279-84.
• Moritz ML, Ayus JC. Prevention of hospital-acquired hyponatremia: a case for using isotonic saline. Pediatrics. 2003 Feb;111(2):227-30. Review.
• Neville KA, Verge CF, Rosenberg AR, O'Meara MW, Walker JL. Isotonic is better than hypotonic saline for intravenous rehydration of children with gastroenteritis: a prospective randomised study. Arch Dis Child. 2006 Mar;91(3):226-32. Epub 2005 Dec 13.
• Saba TG, Fairbairn J, Houghton F, Laforte D, Foster BJ. A randomized controlled trial of isotonic versus hypotonic maintenance intravenous fluids in hospitalized children. BMC Pediatr. 2011 Sep 23;11:82.

Inclusion Criteria:

• 1 month to 18 years of age
• Require IV fluids for at least 8 hr.
• Baseline serum sodium >=136 mmol/L & <=145 mmol/L

Exclusion Criteria:

• Baseline serum sodium concentration less than 136 mmol/L or greater than 145 mmol/L
• Renal disease, a history of cardiac dysfunction or evidence of cardiac dysfunction, pre-existing hypertension, diuretic use, edema, or known adrenal dysfunction
• Acute neurological illness such as meningitis or encephalitis
• Severe chronic neurological illnesses (uncontrolled seizure disorders, severe developmental delay)