Two Bag System for Hydration in Diabetes

Diabetes Clinical Trial

Official title:

Two Bag System vs. One Bag System for Hydration Patients With Diabetic Ketoacidosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01631929
• Other study ID #: 65-HGNPE-2012
• Status: Terminated
• Phase: N/A
• First received: June 25, 2012
• Last updated: September 23, 2015
• Start date: August 2012
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Hospital General de Niños Pedro de Elizalde
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Ketoacidosis

Intervention

Other:
• One bag
Infusion of dextrose and electrolytes using one bag
• 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.

Locations

Country	Name	City	State
Argentina	Hospital General de NIños Pedro de Elizalde	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Niños Pedro de Elizalde

Country where clinical trial is conducted

Argentina, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 werer followed for the duration of ketoacidosis	Yes