Status:
COMPLETED
0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Hyponatremia
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to compare the mean serum sodium at 48 hours following the initiation of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in children requiri...
Detailed Description
Hyponatremia, has become increasingly recognized as a cause of morbidity and mortality in hospitalized children. The main etiology of hyponatremia in these children has been attributed to the use of h...
Eligibility Criteria
Inclusion
- Aged 1 month to 18 years
- Anticipated hospitalization \>48 hours
- Initial plasma Na between 135-145 mmol/L, with a management plan(determined by the responsible physician) to include IV fluids at \> 80% of maintenance
- For children who have had an IV saline bolus, it must have been completed three or more hours prior to having baseline bloods
- Baseline bloods must be drawn within 3 hours of initial patient contact.
Exclusion
- Diagnosed with, or clinically suspected to have, any of the following: dehydration/gastroenteritis, heart or liver failure, portal hypertension with ascites, metabolic disease, SIADH, diabetes insipidus or mellitus, hypertension, adrenal insufficiency, renal failure \[creatinine\>100 μmol/L (\<3 years); \>150 μmol/L (\> 3 years)\], nephritic or nephrotic syndrome, Kawasaki disease, Sickle cell disease if requiring hyperhydration.
- Clinically edematous
- On diuretic medications
- Plasma glucose is \>15 mmol/L
- Require CCU admission
- Any patients requiring IV maintenance therapy having conditions/diseases not listed as excluded are eligible to be in this study
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00632775
Start Date
December 1 2007
End Date
September 1 2012
Last Update
August 26 2013
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8