Hyperglycemia
Conditions
Keywords
Hyperglycemia, Glycemic control
Brief summary
Glycemic control can be safely achieved in surgical and medical intensive care unit settings and has been shown to improve short and long-term clinical outcomes. As such, insulin infusion protocols are routinely used in the ICU setting. The investigators plan to establish the use of strict glycemic control in a heterogenous group of acutely ill patients in the ED setting. The investigators propose to study the aspects of implementing a strict glycemic control protocol in the ED.
Interventions
DRUGInsulin
Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL
Sponsors
Temple University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with blood glucose ≥130 mg% considered to be critically ill as defined by: APACHE II score ≥9 (See Appendix 1) OR \>2 SIRS criteria with lactate ≥ 4 or BP \< 90mmHg despite one liter of fluid OR Evidence of Organ Dysfunction (see Appendix 1)
Exclusion criteria
* Patients requiring urgent interventional procedure (e.g. cardiac catheterization, dialysis) or surgery performed outside of the ED.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Achieve Glycemic Control | Study duration 6 hours. Blood glucose checked at 30 minutes then every 15 minutes until within target blood glucose range then every hour. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Insulin Infusion All subjects placed on insulin infusion.
Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Insulin Infusion |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Time to Achieve Glycemic Control
Time frame: Study duration 6 hours. Blood glucose checked at 30 minutes then every 15 minutes until within target blood glucose range then every hour.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Infusion | Time to Achieve Glycemic Control | 225 Minutes | Standard Deviation 48.8 |