Intravenous Fluids in Adults With Diabetic Ketoacidosis in the Emergency Department (BRISK-ED)
Diabetic Ketoacidosis
About this trial
This is an interventional treatment trial for Diabetic Ketoacidosis focused on measuring randomized controlled trial, emergency department, intravenous fluids, normal saline, Ringer's lactate/balanced crystalloid
Eligibility Criteria
Inclusion Criteria:
There are no definitive criteria for diagnosing DKA.3 Thus, using the criteria employed by Self et al.8 and the Diabetes Canada guidelines3 we will include ED patients ≥18 years with a clinical diagnosis and laboratory values consistent with DKA, including:
- plasma glucose concentration ≥14mmol/L
- plasma bicarbonate concentration ≤18mmol/L and/or blood pH ≤7.30
- calculated anion gap >10mmol/L
- presence of ketones/beta-hydroxybutyrate in serum and/or urine
Exclusion Criteria:
We will exclude patients who:
- Are initially seen at another ED and transferred to LHSC for care and/or admission
- Receive >1L of IV fluid prior to enrolment (e.g. pre-hospital by EMS or while waiting to be seen) - this may cause study contamination
- Are initially enrolled due to clinical suspicion of DKA based on elevated point-of-care glucose, but ultimately do not meet clinical/laboratory criteria for DKA (e.g. "hyperglycemia" only)
- Have euglycemic DKA (generally those on SGLT-2 inhibitors)
Sites / Locations
- London Health Sciences Centre - Victoria Campus
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ringer's lactate
Normal saline
The intervention is administration of IV Ringer's lactate. Rate of study fluid will be at the treating physician's (both ED and inpatient, if consulted for admission) discretion. Apart from fluid administered, there will be no other changes to the patient's clinical care, and patients will receive standard DKA treatment which may include insulin, electrolyte replacement, and/or supportive management. Pharmacy-prepared kits of 8 x 1L bags of study fluid (in Self et al., a maximum of 7090mL was given8) will be kept in a secure space within the ED. Once packaged, IV bags are useable for 30 days before expiration. If a kit is opened but not used completely, individual 1L bags may be returned to the pharmacy to save on costs.
The comparator is administration of IV normal saline. Rate of study fluid will be at the treating physician's (both ED and inpatient, if consulted for admission) discretion. Apart from fluid administered, there will be no other changes to the patient's clinical care, and patients will receive standard DKA treatment which may include insulin, electrolyte replacement, and/or supportive management. Pharmacy-prepared kits of 8 x 1L bags of study fluid (in Self et al., a maximum of 7090mL was given8) will be kept in a secure space within the ED. Once packaged, IV bags are useable for 30 days before expiration. If a kit is opened but not used completely, individual 1L bags may be returned to the pharmacy to save on costs.