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Hyponatremia associated with administration of hypotonic intravenous (IV) fluids may have serious complications. It has recently been suggested that isotonic saline may be a more appropriate choice of maintenance IV fluid. This pilot and feasibility study aims to compare isotonic saline to 0.45% saline in hospitalized children requiring parenteral fluid support in order to:
Aim 1: To determine the feasibility of conducting a double-blind, randomized controlled trial comparing these solutions.
Aim 2a: To compare the rate of change in serum Na (mmol/L/hr) and the incidence of hyponatremia (Na <136 mmol/L) between patients receiving isotonic and hypotonic intravenous fluids at at least 50% of the traditional maintenance rate for an interval of at least 8 hours.
Aim 2b: To compare the incidence of adverse events between the two IV fluid treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 0.9% saline in 5% dextrose (intravenous) |
|
| B | Active Comparator | 0.45% saline in 5% dextrose (intravenous) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9% saline in 5% dextrose (intravenous) | Drug |
|
| |
| 0.45% saline in 5% dextrose (intravenous) |
| Measure | Description | Time Frame |
|---|---|---|
| rate of change in serum sodium | 8 to 20 hours |
| Measure | Description | Time Frame |
|---|---|---|
| hypertension | 8 to 20 hours | |
| congestive heart failure | 8 to 20 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bethany J Foster, MD, MSCE | Montreal Children's Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Children's Hospital | Montreal | Quebec | H3H 1P3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15121942 | Result | Hoorn EJ, Geary D, Robb M, Halperin ML, Bohn D. Acute hyponatremia related to intravenous fluid administration in hospitalized children: an observational study. Pediatrics. 2004 May;113(5):1279-84. doi: 10.1542/peds.113.5.1279. | |
| 12563043 | Result | Moritz ML, Ayus JC. Prevention of hospital-acquired hyponatremia: a case for using isotonic saline. Pediatrics. 2003 Feb;111(2):227-30. doi: 10.1542/peds.111.2.227. |
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| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D001988 | Bronchiolitis |
| D018805 | Sepsis |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Drug |
|
| 16352625 | Result | Neville KA, Verge CF, Rosenberg AR, O'Meara MW, Walker JL. Isotonic is better than hypotonic saline for intravenous rehydration of children with gastroenteritis: a prospective randomised study. Arch Dis Child. 2006 Mar;91(3):226-32. doi: 10.1136/adc.2005.084103. Epub 2005 Dec 13. |
| 21943218 | Derived | Saba TG, Fairbairn J, Houghton F, Laforte D, Foster BJ. A randomized controlled trial of isotonic versus hypotonic maintenance intravenous fluids in hospitalized children. BMC Pediatr. 2011 Sep 23;11:82. doi: 10.1186/1471-2431-11-82. |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D017670 |
| Sodium Compounds |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |