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Two Bag System for Hydration in Diabetes

NCT01631929 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-02-09

Study results available
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Summary

This is a randomized controlled trial comparing the time needed to get the conditions to space hourly controls to controls every 4 hours, using the one bag system versus the two bags system, in the initial treatment of children with diabetic ketoacidosis. After fast infusion of isotonic saline solution (20 ml/kg) to prevent shock, the administration of maintenance fluids and insulin therapy is indicated. Hourly plasmatic levels of glucose controls could determine changes in glucose IV administration. On using the classic one bag system each change determine a bag change. Using the two bag system allows to deliver the patient the appropriate glucose infusion in less time.

Conditions

Interventions

OTHER

One bag

Infusion of dextrose and electrolytes using one bag

OTHER

Two bags

Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.

Sponsors & Collaborators

  • Hospital General de Niños Pedro de Elizalde

    lead OTHER

Principal Investigators

  • Juan P Ferrira, MD · Hospital General de Niños Pedro de Elizalde

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-05-31
Completion
2014-07-31

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Diseases

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 NCT01631929 on ClinicalTrials.gov