Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

Phase 3

Completed

• Conditions: Gastroenteritis; Bronchiolitis; Sepsis; Urinary Tract Infection
• Interventions: Drug: 0.9% saline in 5% dextrose (intravenous); Drug: 0.45% saline in 5% dextrose (intravenous)

• Registration Number: NCT00457873
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-04-05
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-09
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	0.9% saline in 5% dextrose (intravenous)	0.9% saline in 5% dextrose (intravenous)
B	0.45% saline in 5% dextrose (intravenous)	0.45% saline in 5% dextrose (intravenous)

Primary Outcome Measures

Name	Time	Method
rate of change in serum sodium	8 to 20 hours

Secondary Outcome Measures

Name	Time	Method
hypertension	8 to 20 hours
congestive heart failure	8 to 20 hours

Trial Locations

Locations (1)

Montreal Children's Hospital; 🇨🇦 Montreal, Quebec, Canada