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Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy

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ClinicalTrials.gov Identifier: NCT00457873
Recruitment Status : Completed
First Posted : April 9, 2007
Last Update Posted : May 22, 2008
Sponsor:
Information provided by:
McGill University Health Center

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.


Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Isotonic Versus Hypotonic Saline for Maintenance Intravenous Fluid Therapy: A Pilot Randomized Trial
Study Start Date : January 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose
U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. rate of change in serum sodium [ Time Frame: 8 to 20 hours ]

Secondary Outcome Measures :
  1. hypertension [ Time Frame: 8 to 20 hours ]
  2. congestive heart failure [ Time Frame: 8 to 20 hours ]


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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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
First Posted: April 9, 2007    Key Record Dates
Last Update Posted: May 22, 2008
Last Verified: May 2008

Keywords provided by McGill University Health Center:
surgery

Additional relevant MeSH terms:
Urinary Tract Infections
Bronchiolitis
Gastroenteritis
Infection
Urologic Diseases
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Gastrointestinal Diseases
Digestive System Diseases