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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hyponatremia

Intervention / Treatment
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* Drug: Hypotonic (0.45% NaCl/5% dextrose) IV maintenance fluids
* Drug: Isotonic (0.9% NaCl/5% dextrose) IV maintenance fluids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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<br>* 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.<br>* Other names: 0.45% Sodium Chloride/5% dextrose;|
| Active Comparator: 2<br>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<br>* 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.<br>* Other names: 0.9% Sodium Chloride/5% Dextrose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, Hyponatremia, Sodium Chloride, maintenance fluids