Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Sepsis, Gastroenteritis, Bronchiolitis, Urinary Tract Infection

Intervention / Treatment
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* Drug: 0.9% saline in 5% dextrose (intravenous)
* Drug: 0.45% saline in 5% dextrose (intravenous)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>0.9% saline in 5% dextrose (intravenous) | Drug: 0.9% saline in 5% dextrose (intravenous)<br> <br> * Other names: isotonic saline;|
| Active Comparator: B<br>0.45% saline in 5% dextrose (intravenous) | Drug: 0.45% saline in 5% dextrose (intravenous)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of change in serum sodium |  | 8 to 20 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypertension |  | 8 to 20 hours | 
| congestive heart failure |  | 8 to 20 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery