Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-04-30

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.

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Detailed Description

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Conditions

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Gastroenteritis Bronchiolitis Sepsis Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

0.9% saline in 5% dextrose (intravenous)

Group Type EXPERIMENTAL

0.9% saline in 5% dextrose (intravenous)

Intervention Type DRUG

B

0.45% saline in 5% dextrose (intravenous)

Group Type ACTIVE_COMPARATOR

0.45% saline in 5% dextrose (intravenous)

Intervention Type DRUG

Interventions

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0.9% saline in 5% dextrose (intravenous)

Intervention Type DRUG

0.45% saline in 5% dextrose (intravenous)

Intervention Type DRUG

Other Intervention Names

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isotonic saline

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)

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No