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Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

This study has been completed.
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00457873
First received: April 5, 2007
Last updated: May 20, 2008
Last verified: May 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Urinary Tract Infections
Bronchial Diseases
Bronchitis
Digestive System Diseases
Gastrointestinal Diseases
Infection
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on November 27, 2014