CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 78 enrolled
Drug / intervention
0.45% NaCl/dextrose 5% +1 moredrug
Likely dose
0.45% NaCl/dextrose 5% 80 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01251770
NCT01251770Phase 3Completed
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Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children

Hospital General de Niños Pedro de Elizalde·interventional·Posted Dec 2, 2010·Updated Mar 3, 2017

In Brief

A Phase 3 clinical trial evaluating 0.45% NaCl/dextrose 5% and 0.3% NaCl/dextrose 5% for Hyponatremia. Completed, enrolled 78 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyponatremia
CountriesArgentina
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2010
Enrollment StartDec 1, 2010
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.6 years ago

Interventions

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.

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.