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Completed

NCT Number: NCT00632775

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.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 0.45% Sodium Chloride/5% dextrose

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.

Other names: 0.9% Sodium Chloride/5% Dextrose

Primary outcomes

  1. Plasma urea, creatinine, glucose and electrolyte levels

    Time frame: At the time of IV start and every 24 hours thereafter

Secondary outcomes

  1. Oral fluid intake

    Time frame: The duration of the patient's participation in the study

  2. Weight

    Time frame: Every 24 hours

  3. Standardized clinical assessment of edema

    Time frame: Every 24 hours

  4. Blood pressure

    Time frame: Every morning

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Mar 11, 2008
Registry last updated
Aug 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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