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

NCT01301274 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2012-03-07

Study results available
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Summary

The primary objective of this study is to compare the mean serum sodium after 48 hours of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill children requiring IV maintenance fluid administration.

Conditions

Interventions

DRUG

hypotonic

0.45% NaCl/5% dextrose IV maintenance fluids

DRUG

isotonic

0.9% NaCl/5% dextrose IV maintenance fluids

Sponsors & Collaborators

  • Hospital General de Niños Pedro de Elizalde

    lead OTHER

Principal Investigators

  • Facundo A Jorro, MD · Hospital General de Niños Pedro de Elizalde

  • Gustavo De Baisi, MD · Hospital General de Niños Pedro de Elizalde

  • Susana Bengoa · Hospital General de Niños Pedro de Elizalde

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Argentina

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01301274 on ClinicalTrials.gov