Two Bag System for Hydration in Diabetes
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Two Bag System vs. One Bag System for Hydration Patients With Diabetic Ketoacidosis |
- 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
| Estimated Enrollment: | 36 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | December 2013 (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 |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| Contact: Juan P Ferreira, MD | + 54 11 47336526 | ferreirajuanpablo@hotmail.com |
| Argentina | |
| Hospital General de NIños Pedro de Elizalde | Recruiting |
| Buenos Aires, Argentina, C1270AAN | |
| Contact: Fernando C Ferrero, MD, PhD + 54 11 43070140 slaip@intramed.net | |
| Principal Investigator: Juan P Ferreira, Md | |
| Sub-Investigator: Mauricio Villareal, MD | |
| Sub-Investigator: Santiago Funes | |
| Principal Investigator: | Juan P Ferrira, MD | Hospital General de Niños Pedro de Elizalde |
More Information
Publications:
| 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 |
| Last Updated: | May 6, 2013 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Keywords provided by Hospital General de Niños Pedro de Elizalde:
|
Diabetes Ketoacidosis Children |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetic Ketoacidosis Ketosis Acidosis Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Acid-Base Imbalance Diabetes Complications |
ClinicalTrials.gov processed this record on May 16, 2013