0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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 requiring maintenance IV fluid administration.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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