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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Subjects in this arm will receive hypotonic (0.45% NaCl/5% dextrose) intravenous (IV) maintenance fluids. |
|
| 2 | Active Comparator | Subjects in this arm will receive isotonic (0.9% NaCl/5% dextrose) intravenous (IV) maintenance fluids. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma urea, creatinine, glucose and electrolyte levels | At the time of IV start and every 24 hours thereafter |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denis Geary, MD | The Hospital for Sick Children, Toronto Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25751673 | Derived | 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. |
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| 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. |
|
|
| Every 24 hours |
| Blood pressure | Every morning |
| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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