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

NCT00632775 | Completed Phase 3 DMC

• 1 other identifier: 1000011114
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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 requiring maintenance IV fluid administration.

Conditions

Hyponatremia

Keywords

pediatrics; Hyponatremia; Sodium Chloride; maintenance fluids

Outcome Measures

Primary Outcomes (1)

• Plasma urea, creatinine, glucose and electrolyte levels

  At the time of IV start and every 24 hours thereafter

Secondary Outcomes (4)

• Oral fluid intake

  The duration of the patient's participation in the study

• Weight

  Every 24 hours

• Standardized clinical assessment of edema

  Every 24 hours

• Blood pressure

  Every morning

Study Arms (2)

1

ACTIVE COMPARATOR

Subjects in this arm will receive hypotonic (0.45% NaCl/5% dextrose) intravenous (IV) maintenance fluids.

Drug: Hypotonic (0.45% NaCl/5% dextrose) IV maintenance fluids

2

ACTIVE COMPARATOR

Subjects in this arm will receive isotonic (0.9% NaCl/5% dextrose) intravenous (IV) maintenance fluids.

Drug: Isotonic (0.9% NaCl/5% dextrose) IV maintenance fluids

Interventions

Hypotonic (0.45% NaCl/5% dextrose) IV maintenance fluids DRUG

Total daily fluid infusion equal to: 100 mls/kg/day for children weighing \<10kg, 1000 mls + 50mls/kg for those weighing 10 to 20 kg, and 1500 mls +20 mls/kg for those \>20kg.

Also known as: 0.45% Sodium Chloride/5% dextrose

1

Isotonic (0.9% NaCl/5% dextrose) IV maintenance fluids DRUG

Total daily fluid infusion equal to: 100 mls/kg/day for children weighing \<10kg, 1000 mls + 50mls/kg for those weighing 10 to 20 kg, and 1500 mls +20 mls/kg for those \>20kg.

Also known as: 0.9% Sodium Chloride/5% Dextrose

2

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Friedman JN, Beck CE, DeGroot J, Geary DF, Sklansky DJ, Freedman SB. Comparison of isotonic and hypotonic intravenous maintenance fluids: a randomized clinical trial. JAMA Pediatr. 2015 May;169(5):445-51. doi: 10.1001/jamapediatrics.2014.3809.

  PMID: 25751673 DERIVED

MeSH Terms

Conditions

Hyponatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Denis Geary, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 11, 2008
• Study Start: December 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 26, 2013

Record last verified: 2013-08

Locations

CA (1)