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Two Bag System for Hydration in Diabetes

Primary Purpose

Diabetes, Ketoacidosis

Status
Terminated
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
One bag
Two bags
Sponsored by
Hospital General de Niños Pedro de Elizalde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Diabetes, Ketoacidosis, Children

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Hospital General de NIños Pedro de Elizalde

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

One bag

Two bags

Arm Description

IV infusion of fluids, electrolytes and dextrose using one bag

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 25, 2012
Last Updated
December 19, 2016
Sponsor
Hospital General de Niños Pedro de Elizalde
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1. Study Identification

Unique Protocol Identification Number
NCT01631929
Brief Title
Two Bag System for Hydration in Diabetes
Official Title
Two Bag System vs. One Bag System for Hydration Patients With Diabetic Ketoacidosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Monitoring Committee found significant & meaningful difference on main outcome
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital General de Niños Pedro de Elizalde

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The treatment of children with diabetic ketoacidosis includes fast infusion of isotonic saline solution to prevent shock (20 ml/kg), and then the administration of maintenance fluids and insulin therapy according to hourly plasmatic glucose levels controls. Finally, after patients stabilization, controls becomes less frequents (each 4 hours). During the stabilization period infusion of glucose is calculated hourly according to plasmatic glucose levels. These modifications in IV infusion can be very frequent, sometimes by the hour, requiring preparation of a new solution for hydration (in a new bag). This procedure takes time, during which the patient continues receiving the previous IV infusion until the changes are effectively made. Therefore, usually changes are not strictly hourly, interfering with the adjustment of the organism to the above mentioned changes. The 2 bag system consists in 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. Using this system allows that changes needed in the administration of fluids and/or dextrose, may be easily and instantly managed by delivering different amounts from each bag to achieve the desired infusion rate without having to replace the bag.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Ketoacidosis
Keywords
Diabetes, Ketoacidosis, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One bag
Arm Type
Active Comparator
Arm Description
IV infusion of fluids, electrolytes and dextrose using one bag
Arm Title
Two bags
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
One bag
Intervention Description
Infusion of dextrose and electrolytes using one bag
Intervention Type
Other
Intervention Name(s)
Two bags
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Achieve Patient Stabilization
Description
Time needed to achieve patient stabilization defined by: Plasmatic glucose < 250 mg/dl Blood pH > 7.3 Plasmatic bicarbonate > 15 mmol/L
Time Frame
Participants were followed for the duration of ketoacidosis (an expected average of 12 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between 1 to 18 years old Diabetic ketoacidosis(plasmatic glucose > 250mg/dl, pH < 7.3, bicarbonate < 15mmol/L, ketonuria and glycosuria) Exclusion Criteria: Patients who already received insulin in the Emergency Department. Patients who, because of their clinical condition, require admission to intensive care unit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan P Ferrira, MD
Organizational Affiliation
Hospital General de Niños Pedro de Elizalde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General de NIños Pedro de Elizalde
City
Buenos Aires
ZIP/Postal Code
C1270AAN
Country
Argentina

12. IPD Sharing Statement

Citations:
PubMed Identifier
15583776
Citation
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.
Results Reference
background
PubMed Identifier
10064682
Citation
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.
Results Reference
result

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Two Bag System for Hydration in Diabetes

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