Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

McGill University

Status and phase

Completed

Phase 3

Conditions

Urinary Tract Infection

Bronchiolitis

Gastroenteritis

Sepsis

Treatments

Drug: 0.9% saline in 5% dextrose (intravenous)

Drug: 0.45% saline in 5% dextrose (intravenous)

Study type

Interventional

Funder types

Other

Identifiers

NCT00457873

PED-06-016

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

1 month to 18 years old

Volunteers

No Healthy Volunteers

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)