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The primary objective of this study is to compare the blood sodium level after 12 hours following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose 5%, in postsurgical hospitalized children requiring maintenance IV fluid administration.
Background: Despite prescription of maintenance IV fluids in hospitalized children is widely used since 1957 (Holiday & Segar), it is not always adequate for children with acute diseases, leading to hyponatremia. This mainly occurs due to a non-physiologic ADH secretion in this group of patients due to nausea, stress, pain, and surgical interventions, and the use of hypotonic maintenance IV fluids.
0.3% NaCl/dextrose 5%, is widely use as IV maintenance fluid in children after surgery. There is evidence suggesting that these IV fluids used in postsurgical hospitalized patients do not provide the adequate amount of sodium they require, leading to an increased risk of developing hyponatremia. Using 0.45% NaCl/dextrose 5% as IV maintenance fluid in these children would prevent hyponatremia, but this treatment has not been totally studied yet.
Study procedures: Hospitalized children who fulfill inclusion criteria and not having any of the exclusion criteria will be considered for the enrolment after written informed consent.
Venous blood samples will be taken at enrollment (baseline) for estimation of serum sodium. After randomization, one group will receive 0.3% NaCl/dextrose 5%, IV, at standard maintenance rate (100 ml/kg for the first 10 kg of body weight, 50 ml/kg for the next 10 kg, and 20 ml/kg for body weight exceeding 20 kg). The second group will receive 0.45% NaCl/dextrose 5%, IV, at the same rate.
Serum sodium will be estimated in both groups after 12 hours of intravenous fluid therapy.
Children who required oral fluids will be excluded from per-protocol analysis, and only analyzed for intention to treat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| half saline | Experimental | Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids. |
|
| third saline | Active Comparator | Subjects in this arm will receive 0.3% NaCl/dextrose 5% intravenous (IV) maintenance fluids. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.45% NaCl/dextrose 5% | Drug | Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m^2 body surface. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sodium Levels | Change from baseline in sodium level after 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| IV Fluid Intake | 12 hours from baseline |
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Inclusion Criteria:
Aged 1 month to 16 years. Initial plasma Na between 135-145 mmol/L. Primary route of fluid administration is anticipated to be intravenous, in the first 12 hours following surgery.
Informed consent of parent/guardian.
Exclusion Criteria:
• Children with illness that have primary fluid and electrolyte imbalance such as:
Shock: Defined as acute circulatory failure resulting in decreased tissue perfusion and manifesting as altered sensorium, hypothermia (<35oC), tachycardia, prolonged capillary filling time (>3 seconds), hypotension (BP < 5th percentile for age), oliguria (<0.5 ml/kg/hr), hypoxemia, hyperlactatemia, requirement of fluid bolus and/ or vasopressors.
Diarrhea and Dehydration: Children presenting with diarrhea and features of dehydration: lethargy, irritability and altered sensorium, thirst, decreased urine output, sunken eyes & dry mucous membranes, loss of skin elasticity.; children with ongoing diarrhea will be excluded even if there is no dehydration.
Fluid Overload: Cirrhosis, Congestive heart failure, Acute and Chronic renal failure, Nephrotic syndrome.
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| Name | Affiliation | Role |
|---|---|---|
| Manuela Dicembrino, md | Hospital de Niños Pedro de Elizalde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Niños Pedro de Elizalde | Buenos Aires | Buenos Aires F.D. | C1270AAN | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16754657 | Background | Choong K, Kho ME, Menon K, Bohn D. Hypotonic versus isotonic saline in hospitalised children: a systematic review. Arch Dis Child. 2006 Oct;91(10):828-35. doi: 10.1136/adc.2005.088690. Epub 2006 Jun 5. | |
| 19818450 | Background | Neville KA, Sandeman DJ, Rubinstein A, Henry GM, McGlynn M, Walker JL. Prevention of hyponatremia during maintenance intravenous fluid administration: a prospective randomized study of fluid type versus fluid rate. J Pediatr. 2010 Feb;156(2):313-9.e1-2. doi: 10.1016/j.jpeds.2009.07.059. Epub 2009 Oct 9. |
| Label | URL |
|---|---|
| Hyponatremia treatment guidelines 2007: expert panel recommendations | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | ClNa 0.3% | maintenance solution with ClNa 0.3% |
| FG001 | ClNa 0.45% | maintenance solution with ClNa 0.45% |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ClNa 0.3% | maintenance solution with ClNa 0.3% |
| BG001 | ClNa 0.45% | maintenance solution with ClNa 0.45% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Sodium Levels | Posted | Mean | Standard Deviation | mEq/L | Change from baseline in sodium level after 12 hours |
|
|
until hospital discharge, average 5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ClNa 0.3% | maintenance solution with ClNa 0.3% |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nervous system disorders | Nervous system disorders | Non-systematic Assessment | seizures, coma, headache. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hyponatremia | Metabolism and nutrition disorders | Systematic Assessment | serum sodium between 130-134.9 meq/L |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Facundo Jorro Barón | Hospital General de Niños Pedro de Elizalde | 00541143632100 | 2035 | jorrobox@yahoo.com.ar |
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| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| D014883 | Water-Electrolyte Imbalance |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 0.3% NaCl/dextrose 5% | Drug | Drug: 0.3% NaCl/dextrose 5% IV maintenance fluids. Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m^2 surface. |
|
|
| 18036144 | Background | Yung M, Keeley S. Randomised controlled trial of intravenous maintenance fluids. J Paediatr Child Health. 2009 Jan-Feb;45(1-2):9-14. doi: 10.1111/j.1440-1754.2007.01254.x. Epub 2007 Nov 25. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | months |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | IV Fluid Intake | Posted | Mean | Standard Deviation | ml | 12 hours from baseline |
|
|
|
|
| 0 |
| 29 |
| 2 |
| 29 |
| EG001 | ClNa 0.45% | maintenance solution with ClNa 0.45% | 0 | 29 | 5 | 29 |
|
|
| hypernatremia | Metabolism and nutrition disorders | Systematic Assessment | serum sodium more than 145 mEq/L |
|
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