ED Management of Severe Hyperglycemia: An Open-Label Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 110
- Locations
- 2
- Primary Endpoint
- ED Length of Stay
Study Overview
Brief Summary
Emergency Department (ED) patients with severe hyperglycemia will be randomized to two treatment goals: discharge glucose less than 600 mg/dL or less than 350 mg/dL.
Randomization is stratified by whether the chief complaint is "High Blood Sugar" in the electronic medical record or other.
Detailed Description
It is common practice to provide insulin and/or intravenous (IV) fluids to lower glucose levels prior to discharge in patients that present with hyperglycemia. There is, however, no data supporting this practice.
A recent retrospective observational cohort study (HSR# 12-3497) of 567 ED patients with severe hyperglycemia demonstrated no association between discharge glucose levels and short-term adverse outcomes at 7 days (return ED visits, diabetic ketoacidosis (DKA), hospitalization, and death).
There were no other short-term adverse outcomes associated with the degree of glycemic control. Less than 1% of patients developed DKA at 7 days. No patients died.
As this was a retrospective study, the conclusions that can be drawn are limited by the lack of randomization and control; it is necessary to conduct a randomized controlled trial to quantify how much time is expended caring for these patients, and gather safety data.
This is important because much time and money is focused on glucose reduction, which may not change short-term outcomes. Furthermore, in retrospective analysis approximately 1.5% of patients receiving therapy for hyperglycemia developed iatrogenic hypoglycemia during the ED stay.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Glucose of more than 400mg/dL but less than 600 mg/dL at any point in the ED
- •Working phone number and willing to discuss health status at 7-10 days via phone
Exclusion Criteria
- •Plan for hospital admission
- •Already received insulin during the ED stay
- •Type 1 diabetes
- •Less than 18 years old
- •Non-English speaking
- •Altered mental status or encephalopathy (unable to provide informed consent)
- •DKA, as determined clinically by the treating physician, without a lab requirement.
- •Critically ill, as determined by the treating physician.
- •Unable to provide informed consent
- •Prisoners
- •Pregnant women
Arms & Interventions
Tight control
Patients in this arm will have a treatment glucose value at ED discharge of 350 mg/dL or lower.
Intervention: Tight control: goal glucose 350 mg/dL or lower (Other)
Loose control
Patients in this arm will have a treatment glucose value at ED discharge of 600 mg/dL or lower.
Intervention: Loose control: goal glucose 600 mg/dL or lower (Other)
Outcomes
Primary Outcomes
ED Length of Stay
Time Frame: This outcome measure is defined as the amount of time elapsed between when the patient is roomed, and when a discharge order is placed, during a single ED encounter, which is generally less than 4 hours.
Time elapsed from when the patient is roomed until the time the MD places discharge order, by review of the Electronic Medical record by a blinded abstractor.
Secondary Outcomes
- Return ED visit for any reason(7 days)
- Return ED visit for hyperglycemia and hospital admission for any reason, excluding trauma(7 days)
- Iatrogenic hypoglycemia(The patient will be followed during a single ED encounter, which is generally less than 4 hours.)
Investigators
Brian Driver
Principal Investigator
Hennepin Healthcare Research Institute