Diabetic Ketoacidosis
Conditions
Keywords
Emergency department, Insulin, Adult
Brief summary
The purpose of this study is to determine whether adult DKA patients who present to the emergency department treated with early subcutaneous long acting insulin versus standard care receive a shorter total duration of intravenous (IV) insulin infusion.
Detailed description
Specific Aims: To evaluate the impact of early administration of subcutaneous glargine versus standard care on time of insulin infusion in DKA patients and other secondary outcomes listed in this application. Methods: DKA patients enrolled in this study will receive the long acting glargine dose (0.3 units/kg with a maximum dose of 30 units) within two hours after initiation the IV insulin infusion. Besides timing of the glargine dose, no other changes in standard patient care will occur in those patients enrolled in this study, the same labs will be collected and the insulin infusion will be titrated using the same hospital protocol algorithm. Patients enrolled in the prospective arm will be compared with the retrospective control group, which received standard insulin therapy (subcutaneous insulin glargine administered at least 2 to 3 hours prior to termination of the insulin infusion). There will be 18 patients in this group selected in reverse chronological order from our pre-specified date range of 8/1/2014 to 7/31/2016.
Interventions
OTHEREarly administration of subcutaneous insulin glargine dose
DKA patients in the prospective intervention arm will receive subcutaneous glargine within two hours of starting their intravenous insulin infusion. The dose of glargine is 0.3 units/kg with a maximum dose of 30 units.
OTHERIV insulin infusion
All patients will receive the standard of care which is a protocol based continuous insulin infusion
DRUGIV fluid repletion
0.9% NaCl or Plasmalyte A will be initiated as a continuous infusion for volume repletion. Fluids will be switched to contain potassium if serum potassium is less than 3.3 mEq/L. Fluids will be switched to contain dextrose if the serum glucose is less than 250 mg/dL.
Sponsors
University of Maryland, Baltimore
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Bicarbonate \<18 mg/dL * Anion gap \>16 * Blood glucose \>250 mg/dL * Ketonemia or ketonuria
Exclusion criteria
* Pregnant women * Refused consent * Patient left ED against medical advice
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of intravenous insulin infusion | up to 10 months | Measured in minutes from starting insulin infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to closure of anion gap | up to 10 months | Measured in minutes from starting insulin infusion |
| Time to correction of bicarbonate | up to 10 months | Measured by serum bicarbonate |
| Time to correction of serum pH | up to 10 months | Measured by pH on venous blood gas |
| Time to resolution of high serum glucose (hyperglycemia) | up to 10 months | Measured in minutes from starting insulin infusion |
| Return of DKA within 24 hours | up to 10 months | Indicated by presence of diagnostic criteria within 24 hours of starting insulin infusion |
| Incidence of low serum glucose (hypoglycemia) within 24 hours | up to 10 months | Measure by serum glucose. |
| Total duration of hospital stay | up to 10 months | Measured in days |
Countries
United States
Outcome results
None listed