Mode
Text Size
Log in / Sign up
N/A N=66 Randomized Triple-blind Treatment

Intravenous Fluids in Adults With Diabetic Ketoacidosis in the Emergency Department

Diabetic Ketoacidosis

Enrolled (actual)
66
Serious AEs
21.2%
Results posted
Jan 2025
Primary outcome: Primary: Patient Recruitment Rate (Feasibility Outcome) — 66 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Ringer's lactate (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Primary completion
Dec 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Patient Recruitment Rate (Feasibility Outcome)
66
PRIMARY
Time to DKA Resolution (Efficacy Outcome)
12.7; 15.7
SECONDARY
Time to Insulin Infusion Discontinuation
15.9; 15.5
SECONDARY
Intensive Care Unit Admission
1; 1
SECONDARY
In-hospital Death
0; 0
SECONDARY
Hospital Length of Stay
3.3; 1.4
SECONDARY
Hyper- or Hypo-kalemia Post-emergency Department
24; 12
SECONDARY
In-hospital Acute Kidney Injury (Stage 2 or Greater) Post-emergency Department
4; 3
SECONDARY
Major Adverse Kidney Events
4; 2

Summary

Diabetes mellitus is a common chronic disease. It is estimated that up to 40% of adults may develop diabetes in their lifetime. Patients with poorly controlled blood sugars often visit the emergency department for treatment of potentially dangerous and life-threatening complications of diabetes, including "diabetic ketoacidosis" (DKA), a condition where the body does not have enough insulin or cannot effectively use the insulin that is produced. As a result, the body produces a chemical called "ketones" as another source of energy, which increase the acid levels of blood and impairs organ function throughout the body. In the emergency department, patients with DKA are usually treated with insulin and large amounts of intravenous fluid. Recent research suggests the fluid type used may be important in treating DKA. Normal saline (0.9% sodium chloride) is the most commonly used intravenous fluid in treating DKA, but it has a very high concentration of chloride and can lead to additional acid production when given in large volumes. Ringer's lactate is another type of intravenous fluid that more closely matches the chemistry of fluid in our bodies and in theory, does not increase the acidity of blood. While there may be benefits to giving Ringer's lactate instead of normal saline, past studies have included very few patients and thus, definite recommendations on preferred fluid type still cannot be made. This study's research question is: In adults with DKA, does giving Ringer's Lactate result in faster resolution of DKA compared to normal saline? The investigators hypothesize that patients who are given Ringer's Lactate will have faster resolution of DKA. If the hypothesis is correct, results will provide scientific proof that current diabetic ketoacidosis guidelines should change with respect to fluid choice. In this study, patients with DKA presenting to the emergency department will be randomly assigned to receive either normal saline or Ringer's Lactate. As this is an exploratory (pilot) study, the main goal is to ensure that a larger study will be practical and feasible on a scale involving multiple emergency departments across Canada. Completion of a larger study across multiple sites with more patients will improve our understanding of how fluid choice influences patient-important outcomes such as faster resolution of DKA (meaning patients can leave hospital sooner), fewer admissions to the intensive care unit, fewer deaths and fewer cases of permanent kidney damage. A total of 52 participants (26 per group) will be recruited for this pilot trial. This pilot study will assess the practicality of enrolling patients in London and help identify barriers and problems with running a larger trial. The overall goal is to determine if Ringer's Lactate will resolve DKA faster than normal saline. If this is true, patients may spend less time in the hospital, which benefits both individual patients and the healthcare system overall. If this hypothesis is correct, findings could provide high-level proof to change current practice guidelines and affect DKA management globally.

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04926740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search