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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

Tracking Information
First Submitted Date  ICMJE June 25, 2012
First Posted Date  ICMJE June 29, 2012
Results First Submitted Date  ICMJE August 19, 2015
Results First Posted Date  ICMJE October 26, 2015
Last Update Posted Date February 9, 2017
Study Start Date  ICMJE August 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2012)
Time to Achieve Patient Stabilization [ Time Frame: Participants will be followed for the duration of ketoacidosis, an expected average of 8 hours ]
Time needed to achieve patient stabilization defined by:
  • Plasmatic glucose < 250 mg/dl
  • Blood pH > 7.3
  • Plasmatic bicarbonate > 15 mmol/L
  • Negative ketonuria
  • Negative glycosuria
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Two Bag System for Hydration in Diabetes
Official Title  ICMJE Two Bag System vs. One Bag System for Hydration Patients With Diabetic Ketoacidosis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Ketoacidosis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: One bag
    IV infusion of fluids, electrolytes and dextrose using one bag
    Intervention: Other: 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.
    Intervention: Other: Two bags
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 29, 2014)
12
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2012)
36
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01631929
Other Study ID Numbers  ICMJE 65-HGNPE-2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital General de Niños Pedro de Elizalde
Study Sponsor  ICMJE Hospital General de Niños Pedro de Elizalde
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juan P Ferrira, MD Hospital General de Niños Pedro de Elizalde
PRS Account Hospital General de Niños Pedro de Elizalde
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP