Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00457873

Enrollment

Registered

2007-04-09

Start date

2007-01-31

Completion date

2008-04-30

Last updated

2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis, Gastroenteritis, Sepsis, Urinary Tract Infection

Keywords

surgery

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.

Interventions

DRUG0.9% saline in 5% dextrose (intravenous)

DRUG0.45% saline in 5% dextrose (intravenous)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Years

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)

Design outcomes

Primary

Measure	Time frame
rate of change in serum sodium	8 to 20 hours

Secondary

Measure	Time frame
hypertension	8 to 20 hours
congestive heart failure	8 to 20 hours

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026