drugset / Trial / NCT00457873

Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

NCT00457873

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2007-01
Primary completion
2008-04
Completion
2008-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator sodium chloride Unknown 0.45 % Intravenous
Comparator sodium chloride Unknown 0.9 % Intravenous
Comparator Dextrose Unknown 5 % Intravenous