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Intravenous Fluids in Adults With Diabetic Ketoacidosis in the Emergency Department
NA trial testing Ringer's lactate in Diabetic Ketoacidosis in 74 participants. Completed in 7 December 2022.
| Lead sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 74 |
| Start date | 12 October 2021 |
| Primary completion | 7 December 2022 |
| Estimated completion | 7 December 2022 |
| Sites | 1 location across Canada |
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
18 and older, any sex, with Diabetic Ketoacidosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary feasibility outcome is patient recruitment rate over the one-year study period. We will also measure adherence to the protocol for this pilot study. This pilot is not powered to determine differences in treatment groups; however, a priori outcome definition and accurate outcome assessment is needed to inform the future study.
| Group | Value | 95% CI |
|---|---|---|
| Patient Recruitment Rate | 66 |
Time to DKA resolution (hours), defined as the time elapsed between ED presentation and ketoacidosis resolution, following criteria from the American Diabetes Association Consensus Statement on Hyperglycemic Crises1 (plasma glucose \<11.1 mmol/L and two of: plasma bicarbonate ≥15mmol/L, venous pH \>7.3 or anion gap ≤12mmol/L).
| Group | Value | 95% CI |
|---|---|---|
| Normal Saline | 12.7 | 7.9 – 19.2 |
| Ringer's Lactate | 15.7 | 10.4 – 18.8 |
Time to insulin infusion discontinuation
| Group | Value | 95% CI |
|---|---|---|
| Ringer's Lactate | 15.9 | 5.7 – 39.2 |
| Normal Saline | 15.5 | 6.7 – 36.4 |
Intensive care unit admission
| Group | Value | 95% CI |
|---|---|---|
| Ringer's Lactate | 1 | |
| Normal Saline | 1 |
In-hospital death
| Group | Value | 95% CI |
|---|---|---|
| Ringer's Lactate | 0 | |
| Normal Saline | 0 |
Hospital length of stay
| Group | Value | 95% CI |
|---|---|---|
| Ringer's Lactate | 3.3 | 2.0 – 6.1 |
| Normal Saline | 1.4 | 0.3 – 5.8 |
\>6.0 or \<3.0 mmol/L
| Group | Value | 95% CI |
|---|---|---|
| Ringer's Lactate | 24 | |
| Normal Saline | 12 |
Serum creatinine increase \>200% from baseline or \<0.5mL/kg/hr urine output for \<12 hours
| Group | Value | 95% CI |
|---|---|---|
| Ringer's Lactate | 4 | |
| Normal Saline | 3 |
Composite of i) death, ii) new renal replacement therapy, iii) final serum creatinine \>/= 200% baseline at the earliest of hospital discharge or 30 days after ED presentation
| Group | Value | 95% CI |
|---|---|---|
| Ringer's Lactate | 4 | |
| Normal Saline | 2 |
Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Ringer's Lactate | Normal Saline |
|---|---|---|---|
| Major adverse kidney event within 30 days of ED presentation | Renal and urinary disorders | — | — |
| Intubation | Surgical and medical procedures | — | — |
| Intensive Care Unit Admission | General disorders | — | — |
| Acute kidney injury (in-hospital) | Renal and urinary disorders | — | — |
Most-reported serious reactions: Major adverse kidney event within 30 days of ED presentation, Intubation, Intensive Care Unit Admission, Acute kidney injury (in-hospital).
Data from ClinicalTrials.gov NCT04926740 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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