Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

This study has been completed.
Information provided by:
McGill University Health Center Identifier:
First received: April 5, 2007
Last updated: May 20, 2008
Last verified: May 2008

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.

Condition Intervention Phase
Urinary Tract Infection
Drug: 0.9% saline in 5% dextrose (intravenous)
Drug: 0.45% saline in 5% dextrose (intravenous)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Isotonic Versus Hypotonic Saline for Maintenance Intravenous Fluid Therapy: A Pilot Randomized Trial

Resource links provided by NLM:

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • rate of change in serum sodium [ Time Frame: 8 to 20 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 38
Study Start Date: January 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
0.9% saline in 5% dextrose (intravenous)
Drug: 0.9% saline in 5% dextrose (intravenous)
Other Name: isotonic saline
Active Comparator: B
0.45% saline in 5% dextrose (intravenous)
Drug: 0.45% saline in 5% dextrose (intravenous)


Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT00457873

Canada, Quebec
Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Sponsors and Collaborators
McGill University Health Center
Principal Investigator: Bethany J Foster, MD, MSCE Montreal Children's Hospital Research Institute
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Bethany Foster, Montreal Children's Hospital Identifier: NCT00457873     History of Changes
Other Study ID Numbers: PED-06-016 
Study First Received: April 5, 2007
Last Updated: May 20, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:

Additional relevant MeSH terms:
Urinary Tract Infections
Bronchial Diseases
Digestive System Diseases
Gastrointestinal Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Urologic Diseases processed this record on May 02, 2016