Two Bag System for Hydration in Diabetes

This study is currently recruiting participants.
Verified September 2013 by Hospital General de Niños Pedro de Elizalde
Sponsor:
Information provided by (Responsible Party):
Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier:
NCT01631929
First received: June 25, 2012
Last updated: September 30, 2013
Last verified: September 2013

June 25, 2012
September 30, 2013
August 2012
May 2014   (final data collection date for primary outcome measure)
Time to achieve patient stabilization [ Time Frame: Participants will be followed for the duration of ketoacidosis, an expected average of 8 hours ] [ Designated as safety issue: No ]

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
Same as current
Complete list of historical versions of study NCT01631929 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Two Bag System for Hydration in Diabetes
Two Bag System vs. One Bag System for Hydration Patients With Diabetic Ketoacidosis

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Ketoacidosis
  • 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.
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
July 2014
May 2014   (final data collection date for primary outcome measure)

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.
Both
1 Year to 18 Years
No
Contact: Juan P Ferreira, MD + 54 11 47980847 ferreirajuanpablo@hotmail.com
Argentina
 
NCT01631929
65-HGNPE-2012
No
Hospital General de Niños Pedro de Elizalde
Hospital General de Niños Pedro de Elizalde
Not Provided
Principal Investigator: Juan P Ferrira, MD Hospital General de Niños Pedro de Elizalde
Hospital General de Niños Pedro de Elizalde
September 2013

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