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

Hyponatremia Clinical Trial

Official title:

Randomized, Double Blind, Controlled Trial of 0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632775
• Other study ID #: 1000011114
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2008
• Last updated: August 23, 2013
• Start date: December 2007
• Est. completion date: September 2012

Study information

• Verified date: August 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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 hypotonic maintenance IV fluids. The practice of providing IV solutions containing 20-30 mmol/L of Na is based on "physiological needs" proposed by Holliday and Segarin 1957, derived from studies of 61 adults and children. The presence of non-physiologic ADH secretion in the great majority of hospitalized children due to nausea, stress, pain, and surgical interventions, has confirmed that Holliday and Segar's recommendations are frequently inappropriately applied. To avoid the development of hyponatremia, it has been suggested that isotonic 0.9% NaCl/dextrose 5% should be the standard maintenance IV solution.

The routine use of an isotonic maintenance fluid solution has not yet been studied, and concerns exist regarding the potential for hypernatremia and salt and water overload. If isotonic solutions are to be recommended routinely, their overall safety, and specifically the occurrence of dysnatremias and volume overload, should be evaluated in a controlled prospective trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyponatremia

Intervention

Drug:
• Hypotonic (0.45% NaCl/5% dextrose) IV maintenance fluids
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.
• Isotonic (0.9% NaCl/5% dextrose) IV maintenance fluids
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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma urea, creatinine, glucose and electrolyte levels		At the time of IV start and every 24 hours thereafter	Yes
Secondary	Oral fluid intake		The duration of the patient's participation in the study	No
Secondary	Weight		Every 24 hours	No
Secondary	Standardized clinical assessment of edema		Every 24 hours	No
Secondary	Blood pressure		Every morning	No