Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Gastroenteritis Bronchiolitis Sepsis Urinary Tract Infection	Drug: 0.9% saline in 5% dextrose (intravenous) Drug: 0.45% saline in 5% dextrose (intravenous)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Isotonic Versus Hypotonic Saline for Maintenance Intravenous Fluid Therapy: A Pilot Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis High Blood Pressure Sepsis Urinary Tract Infections

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:

rate of change in serum sodium [ Time Frame: 8 to 20 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

hypertension [ Time Frame: 8 to 20 hours ] [ Designated as safety issue: Yes ]
congestive heart failure [ Time Frame: 8 to 20 hours ] [ Designated as safety issue: Yes ]

Enrollment:	38
Study Start Date:	January 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A 0.9% saline in 5% dextrose (intravenous)	Drug: 0.9% saline in 5% dextrose (intravenous) Other Name: isotonic saline
Active Comparator: B 0.45% saline in 5% dextrose (intravenous)	Drug: 0.45% saline in 5% dextrose (intravenous)

Eligibility

Ages Eligible for Study:	1 Month to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457873

Locations

Canada, Quebec
Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3

Sponsors and Collaborators

McGill University Health Center

Investigators

Principal Investigator:

Bethany J Foster, MD, MSCE

Montreal Children's Hospital Research Institute

More Information

Publications:

Hoorn EJ, Geary D, Robb M, Halperin ML, Bohn D. Acute hyponatremia related to intravenous fluid administration in hospitalized children: an observational study. Pediatrics. 2004 May;113(5):1279-84.

Moritz ML, Ayus JC. Prevention of hospital-acquired hyponatremia: a case for using isotonic saline. Pediatrics. 2003 Feb;111(2):227-30. Review.

Neville KA, Verge CF, Rosenberg AR, O'Meara MW, Walker JL. Isotonic is better than hypotonic saline for intravenous rehydration of children with gastroenteritis: a prospective randomised study. Arch Dis Child. 2006 Mar;91(3):226-32. Epub 2005 Dec 13.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Saba TG, Fairbairn J, Houghton F, Laforte D, Foster BJ. A randomized controlled trial of isotonic versus hypotonic maintenance intravenous fluids in hospitalized children. BMC Pediatr. 2011 Sep 23;11:82.

Responsible Party:	Dr. Bethany Foster, Montreal Children's Hospital
ClinicalTrials.gov Identifier:	NCT00457873 History of Changes
Other Study ID Numbers:	PED-06-016
Study First Received:	April 5, 2007
Last Updated:	May 20, 2008
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:

surgery

Additional relevant MeSH terms:

Bronchiolitis
Gastroenteritis
Sepsis
Urinary Tract Infections
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Tract Infections
Gastrointestinal Diseases
Digestive System Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013