Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis

Launched by THE GEORGE INSTITUTE · Feb 28, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two types of fluids used to treat a serious condition called diabetic ketoacidosis (DKA), which can happen when a person's blood sugar levels are very high. The trial aims to see if using Plasma-Lyte® 148, a balanced electrolyte solution, helps patients spend more days alive and out of the hospital compared to using regular saline. This research will involve patients in the Emergency Department who are critically ill and need to be admitted to a special care area.

To participate in this trial, patients must be 18 years or older and diagnosed with moderate to severe DKA, which is indicated by specific blood test results. They should also have a high blood sugar level and meet other medical criteria. If eligible, participants will receive either Plasma-Lyte® 148 or saline during their treatment, but they will not know which one they are receiving. This study is not yet recruiting, so patients and their families can keep an eye out for updates if they are interested in participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients in the ED with a primary diagnosis of moderate to severe DKA for whom both saline and Plasma-Lyte® 148 are considered appropriate fluids
• • Blood glucose level \> 14mmol/L
• • pH \< 7.25
• • Serum bicarbonate \<15 mmol/L
• • Elevated anion gap \> 12mEq/L
• • Ketones positive on finger prick measurements
• • In the judgement of the treating clinician critical care area admission is required
• Exclusion Criteria:
• • Age less than 18 years
• • Patients who have received more than 2000ml of non study fluid prior to study enrolment
• • Serum Na \> 155 or \<120 mmol/L
• • Contraindication to either study fluid e.g. previous allergic reaction to Plasma-Lyte® 148
• • Patients with hyperosmotic hyperglycaemic non-ketotic syndrome
• • Other clinical conditions that preclude large volumes of fluid resuscitation
• • Previous inclusion in BEST-DKA trial