0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children
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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 |
- 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 ]
- 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 |
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| Canada, Ontario | |
| The Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Principal Investigator: | Denis Geary, MD | The Hospital for Sick Children, Toronto Canada |
More Information
No publications provided
| Responsible Party: | Denis Geary/Principal Investigator, 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: | September 7, 2012 |
| 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 May 23, 2013