Two Bag System for Hydration in Diabetes

This study has been terminated.

(Monitoring Committee found significant & meaningful difference on main outcome)

Sponsor:

Information provided by (Responsible Party):

Hospital General de Niños Pedro de Elizalde

ClinicalTrials.gov Identifier:

NCT01631929

First received: June 25, 2012

Last updated: December 19, 2016

Last verified: December 2016

History of Changes

Purpose

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	Intervention
Diabetes Ketoacidosis	Other: One bag Other: Two bags


Study Type:	Interventional
Study Design:	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

Further study details as provided by Hospital General de Niños Pedro de Elizalde:

Primary Outcome Measures:

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


Enrollment:	12
Study Start Date:	August 2012
Study Completion Date:	July 2014
Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

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.

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.


Responsible Party:	Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier:	NCT01631929 History of Changes
Other Study ID Numbers:	65-HGNPE-2012
Study First Received:	June 25, 2012
Results First Received:	August 19, 2015
Last Updated:	December 19, 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

ClinicalTrials.gov processed this record on September 21, 2017

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