Status:
COMPLETED
Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children
Lead Sponsor:
Hospital General de Niños Pedro de Elizalde
Conditions:
Hyponatremia
Eligibility:
All Genders
1-16 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Postsurgical children admitted to HGNPE Department of Surgery between january 2010 and october 2011.
- 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
- • 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.
- Hyperglycemia: blood glucose \> 180 mg/ dl.
- Require ICU admission.
- Severe Protein Energy Malnutrition: Defined as grade III (50-59% of expected weight for age) and grade IV (less than 50% of expected weight for age) as per IAP classification.
- Patients in whom either hypotonic or isotonic solutions may be contraindicated/necessary: i.e. specific neurosurgical patients (ie those at risk of increased ICP, e.g. requiring actual brain surgery, ICP monitor or external ventricular drain insertion), patients with diabetic ketoacidosis, acute (≤ 7 days) burns, pre-existing CHF, liver failure or cirrhosis, renal failure.
- Patients with known pre-existing risk of PNa derangements: DI or SIADH
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01251770
Start Date
December 1 2010
End Date
July 1 2011
Last Update
March 3 2017
Active Locations (1)
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1
Hospital de Niños Pedro de Elizalde
Buenos Aires, Buenos Aires F.D., Argentina, C1270AAN