NCT00457873

Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

Isotonic Versus Hypotonic Saline for Maintenance Intravenous Fluid Therapy: A Pilot Randomized Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroenteritis
• Bronchiolitis
• Sepsis
• Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	0.9% saline in 5% dextrose (intravenous)
DRUG	0.45% saline in 5% dextrose (intravenous)

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-04-09
• Last updated: 2022-04-12

Locations

1 site across 1 country: Canada