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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Denis Geary, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00632775
First received: March 3, 2008
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Hyponatremia
Drug: Hypotonic (0.45% NaCl/5% dextrose) IV maintenance fluids
Drug: Isotonic (0.9% NaCl/5% dextrose) IV maintenance fluids
Phase 3

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

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Plasma urea, creatinine, glucose and electrolyte levels [ Time Frame: At the time of IV start and every 24 hours thereafter ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Oral fluid intake [ Time Frame: The duration of the patient's participation in the study ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: Every 24 hours ] [ Designated as safety issue: No ]
  • Standardized clinical assessment of edema [ Time Frame: Every 24 hours ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Every morning ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: December 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 0.9% Sodium Chloride/5% Dextrose

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.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632775

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Denis Geary, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

Responsible Party: Denis Geary, Nephrologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00632775     History of Changes
Other Study ID Numbers: 1000011114
Study First Received: March 3, 2008
Last Updated: August 23, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
pediatrics
Hyponatremia
Sodium Chloride
maintenance fluids

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on July 29, 2014