Two Bag System for Hydration in Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes, Ketoacidosis

Intervention / Treatment
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* Other: One bag
* Other: Two bags


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: One bag<br>IV infusion of fluids, electrolytes and dextrose using one bag | Other: One bag<br>* Infusion of dextrose and electrolytes using one bag<br>|
| Experimental: Two bags<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 were followed for the duration of ketoacidosis (an expected average of 12 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Ketoacidosis, Children