Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children

Phase 3 Completed 78 enrolled Hospital General de Niños Pedro de Elizalde

RandomizedParallel-groupDouble-blindTreatment

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 hospitalized children requiring maintenance IV fluid administration.

Timeline

Start: 2010-12
Primary completion: 2011-07
Completion: 2011-07

Publications

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.
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.
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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	0.3% NaCl/dextrose 5%	Unknown	—	Intravenous
Subject	0.45% NaCl/dextrose 5%	Unknown	—	Intravenous

Indications

No indication recorded.