Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

McGill University Health Centre/Research Institute of the McGill University Health Centre38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Gastroenteritis Bronchiolitis Sepsis Urinary Tract Infection

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

rate of change in serum sodium

Time frame: 8 to 20 hours

Secondary Outcomes

hypertension

Time frame: 8 to 20 hours

congestive heart failure

Time frame: 8 to 20 hours

Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes