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NCT Number: NCT00457873

Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

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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Key information

Conditions

Gastroenteritis Bronchial Diseases Bronchiolitis Bronchitis Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Infections Inflammation Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Sepsis Systemic Inflammatory Response Syndrome Urinary Tract Infection Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

0.9% saline in 5% dextrose (intravenous)

Drug

Other names: isotonic saline

0.45% saline in 5% dextrose (intravenous)

Drug

Primary outcomes

  1. rate of change in serum sodium

    Time frame: 8 to 20 hours

Secondary outcomes

  1. hypertension

    Time frame: 8 to 20 hours

  2. congestive heart failure

    Time frame: 8 to 20 hours

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 9, 2007
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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