Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children (surgical-Na)
|Hyponatremia||Drug: 0.45% NaCl/dextrose 5% Drug: 0.3% NaCl/dextrose 5%||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children|
- Change in Sodium Levels [ Time Frame: Change from baseline in sodium level after 12 hours ]
- IV Fluid Intake [ Time Frame: 12 hours from baseline ]
|Study Start Date:||December 2010|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: half saline
Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.
Drug: 0.45% NaCl/dextrose 5%
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.
Other Name: half saline
Active Comparator: third saline
Subjects in this arm will receive 0.3% NaCl/dextrose 5% intravenous (IV) maintenance fluids.
Drug: 0.3% NaCl/dextrose 5%
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.
Other Name: third saline
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251770
|Hospital de Niños Pedro de Elizalde|
|Buenos Aires, CF, Argentina, C1270AAN|
|Principal Investigator:||Manuela Dicembrino, md||Hospital de Niños Pedro de Elizalde|