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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Ketoacidosis | Other: One bag Other: Two bags | Not Applicable |
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 : | 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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: One bag
IV infusion of fluids, electrolytes and dextrose using one bag
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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. |
- 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

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Ages Eligible for Study: | 1 Year to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Argentina | |
Hospital General de NIños Pedro de Elizalde | |
Buenos Aires, Argentina, C1270AAN |
Principal Investigator: | Juan P Ferrira, MD | Hospital General de Niños Pedro de Elizalde |
Other Publications:
Responsible Party: | Hospital General de Niños Pedro de Elizalde |
ClinicalTrials.gov Identifier: | NCT01631929 |
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 |
Diabetes Ketoacidosis Children |
Ketosis Acidosis Metabolic Diseases Acid-Base Imbalance |