NCT01631929

Brief 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 26, 2015

Completed
Last Updated

February 9, 2017

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

June 25, 2012

Results QC Date

August 19, 2015

Last Update Submit

December 19, 2016

Conditions

DiabetesKetoacidosis

Keywords

DiabetesKetoacidosisChildren

Outcome Measures

Primary Outcomes (1)

  • Time to Achieve Patient Stabilization

    Time needed to achieve patient stabilization defined by: * Plasmatic glucose \< 250 mg/dl * Blood pH \> 7.3 * Plasmatic bicarbonate \> 15 mmol/L

    Participants were followed for the duration of ketoacidosis (an expected average of 12 hours)

Study Arms (2)

One bag

ACTIVE COMPARATOR

IV infusion of fluids, electrolytes and dextrose using one bag

Other: One bag

Two bags

EXPERIMENTAL

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.

Other: Two bags

Interventions

One bagOTHER

Infusion of dextrose and electrolytes using one bag

One bag
Two bagsOTHER

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.

Two bags

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients between 1 to 18 years old
  • Diabetic ketoacidosis(plasmatic glucose \> 250mg/dl, pH \< 7.3, bicarbonate \< 15mmol/L, ketonuria and glycosuria)

You may not qualify if:

  • Patients who already received insulin in the Emergency Department.
  • Patients who, because of their clinical condition, require admission to intensive care unit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de NIños Pedro de Elizalde

Buenos Aires, C1270AAN, Argentina

Location

Related Publications (2)

  • Poirier MP, Greer D, Satin-Smith M. A prospective study of the "two-bag system'' in diabetic ketoacidosis management. Clin Pediatr (Phila). 2004 Nov-Dec;43(9):809-13. doi: 10.1177/000992280404300904.

    PMID: 15583776BACKGROUND

  • Grimberg A, Cerri RW, Satin-Smith M, Cohen P. The "two bag system" for variable intravenous dextrose and fluid administration: benefits in diabetic ketoacidosis management. J Pediatr. 1999 Mar;134(3):376-8. doi: 10.1016/s0022-3476(99)70469-5.

    PMID: 10064682RESULT

MeSH Terms

Conditions

Diabetes MellitusKetosis

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAcidosisAcid-Base Imbalance

Results Point of Contact

Title
Ferreira Juan Pablo MD
Organization
HOSPITAL GENERAL DE NIÑOS PEDRO DE ELIZALDE
ferreirajuanpablo@hotmail.com
+5491136085959

Study Officials

  • Juan P Ferrira, MD

    Hospital General de Niños Pedro de Elizalde

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2012

First Posted

June 29, 2012

Study Start

August 1, 2012

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

February 9, 2017

Results First Posted

October 26, 2015

Record last verified: 2016-12

Locations

AR(1)