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

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

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.

Study Overview

• Status: Completed
• Conditions: Hyponatremia
• Intervention / Treatment: Drug: Hypotonic (0.45% NaCl/5% dextrose) IV maintenance fluids; Drug: Isotonic (0.9% NaCl/5% dextrose) IV maintenance fluids

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 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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; 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; 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.; Other Names: 0.45% Sodium Chloride/5% dextrose
Active Comparator: 2; 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; 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.; Other Names: 0.9% Sodium Chloride/5% Dextrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma urea, creatinine, glucose and electrolyte levels	At the time of IV start and every 24 hours thereafter

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Denis Geary, MD, The Hospital for Sick Children, Toronto Canada

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: March 3, 2008
• First Submitted That Met QC Criteria: March 3, 2008
• First Posted (Estimate): March 11, 2008

Study Record Updates

• Last Update Posted (Estimate): August 26, 2013
• Last Update Submitted That Met QC Criteria: August 23, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: pediatrics; Hyponatremia; Sodium Chloride; maintenance fluids
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyponatremia
• Other Study ID Numbers: 1000011114