0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children

Hyponatremia Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyponatremia

• NCT number: NCT00632775
• Study type: Interventional
• Source: The Hospital for Sick Children
• Status: Completed
• Phase: Phase 3
• Start date: December 2007
• Completion date: September 2012