Diabetic Ketoacidosis
Conditions
Keywords
Pediatrics, Diabetes, Emergency Care, Endocrinology, Critical Care
Brief summary
The purpose of this study is to determine the effects of the addition of insulin glargine during the early phase of moderate to severe Diabetic Ketoacidosis (DKA) in children. The investigators hypothesize that the addition of insulin glargine during the early phase of management of DKA will accelerate acidosis correction, decrease the length of insulin infusion, and decrease the total intensive care unit time in children admitted to the ICU.
Interventions
DRUGglargine
0.3u/kg of glargine, subcutaneously, once
DRUGsaline
0.3u/kg of saline, subcutaneously, once
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Ages 6-18 y.o. presenting to Vanderbilt Children's Hospital (VCH) Emergency Room with: * Established history of insulin dependent diabetes AND: * Chief c/o hyperglycemia or vomiting * Venous pH \< 7.24 * Serum Bicarbonate \< 18 * Blood glucose \> 150 * Urinary Ketones
Exclusion criteria
* Age \< 6y.o. * New onset diabetes * Received IV insulin bolus prior to arrival to VCH Emergency Room (ER) * Venous pH \> 7.24 * Serum Bicarbonate \> 18 * Pregnancy * Received glargine within 12 hours prior to arrival to VCH Emergency Room/Pediatric Critical Care Unit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of Acidosis Correction | Minutes | Unable to find any data on this study. PI left Vanderbilt and there was not a publication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time on Insulin Drip | Minutes | Unable to find any data on this study. PI left Vanderbilt and there was not a publication. |
| Total Hospital Stay | Days | Unable to find any data on this study. PI left Vanderbilt and there was not a publication. |
Countries
United States
Participant flow
Pre-assignment details
Original data cannot be found. PI has left Vanderbilt and does not know where records are located. Total enrollment and completion date was obtained from Institutional Review Board records.
Participants by arm
| Arm | Count |
|---|---|
| Glargine 0.3u/kg of glargine, subcutaneously, once
glargine: 0.3u/kg of glargine, subcutaneously, once | 0 |
| Placebo 0.3u/kg of saline, subcutaneously, once
saline: 0.3u/kg of saline, subcutaneously, once | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Time of Acidosis Correction
Unable to find any data on this study. PI left Vanderbilt and there was not a publication.
Time frame: Minutes
Secondary
Time on Insulin Drip
Unable to find any data on this study. PI left Vanderbilt and there was not a publication.
Time frame: Minutes
Secondary
Total Hospital Stay
Unable to find any data on this study. PI left Vanderbilt and there was not a publication.
Time frame: Days