Diabetes, Ketoacidosis
Conditions
Keywords
Diabetes, Ketoacidosis, Children
Brief 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.
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.
Interventions
OTHEROne bag
Infusion of dextrose and electrolytes using one bag
OTHERTwo 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.
Sponsors
Hospital General de Niños Pedro de Elizalde
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Achieve Patient Stabilization | 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 |
Countries
Argentina
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| One Bag IV infusion of fluids, electrolytes and dextrose using one bag
One bag: Infusion of dextrose and electrolytes using one bag | 6 |
| 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.
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. | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | One Bag | Two Bags | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.83 years STANDARD_DEVIATION 1.7 | 9.67 years STANDARD_DEVIATION 2.7 | 9.2 years STANDARD_DEVIATION 3.4 |
| Disease debuted Not | 2 participants | 4 participants | 6 participants |
| Disease debuted Yes | 4 participants | 2 participants | 6 participants |
| Gender Female | 5 Participants | 5 Participants | 10 Participants |
| Gender Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
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
Time frame: Participants were followed for the duration of ketoacidosis (an expected average of 12 hours)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| One Bag | Time to Achieve Patient Stabilization | 13.3 Hours |
| Two Bags | Time to Achieve Patient Stabilization | 9.8 Hours |