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Two Bag System for Hydration in Diabetes

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ClinicalTrials.gov Identifier: NCT01631929
Recruitment Status : Terminated (Monitoring Committee found significant & meaningful difference on main outcome)
First Posted : June 29, 2012
Results First Posted : October 26, 2015
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital General de Niños Pedro de Elizalde

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Ketoacidosis Other: One bag Other: Two bags Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Two Bag System vs. One Bag System for Hydration Patients With Diabetic Ketoacidosis
Study Start Date : August 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: One bag
IV infusion of fluids, electrolytes and dextrose using one bag
 Other: One bag
Infusion of dextrose and electrolytes using one bag
Experimental: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Time to Achieve Patient Stabilization [ Time Frame: Participants were followed for the duration of ketoacidosis (an expected average of 12 hours) ]

    Time needed to achieve patient stabilization defined by:

    • Plasmatic glucose < 250 mg/dl
    • Blood pH > 7.3
    • Plasmatic bicarbonate > 15 mmol/L


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631929


Locations
Argentina
Hospital General de NIños Pedro de Elizalde
Buenos Aires, Argentina, C1270AAN
Sponsors and Collaborators
Hospital General de Niños Pedro de Elizalde
Investigators
Principal Investigator: Juan P Ferrira, MD Hospital General de Niños Pedro de Elizalde
More Information
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Publications of Results:

Other Publications:

Responsible Party: Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier: NCT01631929     History of Changes
Other Study ID Numbers: 65-HGNPE-2012
First Posted: June 29, 2012    Key Record Dates
Results First Posted: October 26, 2015
Last Update Posted: February 9, 2017
Last Verified: December 2016

Keywords provided by Hospital General de Niños Pedro de Elizalde:
Diabetes
Ketoacidosis
Children

Additional relevant MeSH terms:
Ketosis
Acidosis
Acid-Base Imbalance
Metabolic Diseases