Clinical trial NCT00457873: Isotonic Versus Hypotonic Fluid for Maintenance IV Therapy
Official title: Isotonic Versus Hypotonic Saline for Maintenance Intravenous Fluid Therapy: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroenteritis
Bronchiolitis
Sepsis
Urinary Tract Infection
Keywords: surgery
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2007-04-09
Enrollment: 38
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: rate of change in serum sodium
timeFrame: 8 to 20 hours
Secondary outcomes:
measure: hypertension
timeFrame: 8 to 20 hours
measure: congestive heart failure
timeFrame: 8 to 20 hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
Study officials:
affiliation: Montreal Children's Hospital Research Institute
name: Bethany J Foster, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1542/peds.113.5.1279.
citation: Moritz ML, Ayus JC. Prevention of hospital-acquired hyponatremia: a case for using isotonic saline. Pediatrics. 2003 Feb;111(2):227-30. doi: 10.1542/peds.111.2.227.
citation: 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. doi: 10.1136/adc.2005.084103. Epub 2005 Dec 13.
citation: 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. doi: 10.1186/1471-2431-11-82.