Which IV fluid helps DKA patients leave the hospital faster?
NCT ID NCT05752279
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests whether a balanced electrolyte solution (Plasma-Lyte 148) helps people with moderate to severe diabetic ketoacidosis recover faster than standard saline. About 680 critically ill adults in the emergency department will be randomly assigned to one of the two fluids. The main goal is to see which fluid leads to more days alive and out of the hospital within 28 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Plasma-Lyte 148 (balanced multi-electrolyte solution) and 0.9% sodium chloride (normal saline)
- What this could lead to
- If Plasma-Lyte works better, it could become the standard fluid for diabetic ketoacidosis, helping patients recover faster and spend fewer days in the hospital.
- What could go wrong
- This is a large phase 3 trial, but the difference between the two fluids may be small or not significant. Results may not apply to all patients with DKA.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 680 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2024
- Expected to finish
-
Jul 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diabetic ketoacidosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
21 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Ballarat Base Hospital
RECRUITINGBallarat, Victoria, 3350, Australia
-
Blacktown Hospital
RECRUITINGBlacktown, New South Wales, 2148, Australia
-
Caboolture Hospital
RECRUITINGCaboolture, Queensland, Australia
-
Camperdown Hospital
RECRUITINGCamperdown, New South Wales, 2050, Australia
-
Dandenong Hospital
RECRUITINGDandenong, Victoria, 3175, Australia
-
Dubbo Base Hospital
RECRUITINGDubbo, New South Wales, 2830, Australia
-
Frankston Hospital - Peninsula Health
RECRUITINGFrankston, Victoria, 3199, Australia
-
Gold Coast University Hospital
RECRUITINGSouthport, Queensland, 4215, Australia
-
Latrobe Regional Hospital
RECRUITINGTraralgon, Victoria, 3844, Australia
-
Lyell McEwin Hospital
RECRUITINGElizabeth Vale, South Australia, 5112, Australia
-
Maitland Hospital
RECRUITINGMetford, New South Wales, 2323, Australia
-
Monash Health-Casey Hospital
RECRUITINGBerwick, Victoria, 3806, Australia
-
Orange Hospital
RECRUITINGOrange, New South Wales, 2800, Australia
-
Queen Elizabeth II Jubilee Hospital
RECRUITINGCoopers Plains, Queensland, 4108, Australia
-
Redcliffe Hospital
RECRUITINGRedcliffe, Queensland, 4020, Australia
-
Rockhampton Hospital
RECRUITINGRockhampton, Queensland, 4700, Australia
-
Royal North Shore Hospital
RECRUITINGSt Leonards, New South Wales, 2065, Australia
-
St George Hospital
RECRUITINGKogarah, New South Wales, 2217, Australia
-
Sunshine Coast University Hospital
RECRUITINGBirtinya, Queensland, 4575, Australia
-
The Queen Elizabeth Hospital
RECRUITINGWoodville South, South Australia, 5011, Australia
-
Westmead Hospital
RECRUITINGWestmead, New South Wales, 2145, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A routine blood count may reveal how severe diabetic ketoacidosis will be
- A finger pulse reading may reveal how dangerous diabetic ketoacidosis is
- Should DKA patients fast or feast? trial tests early eating in the ICU
- Could a simple vitamin speed recovery from a dangerous diabetes complication?
- New study checks for hidden organ damage in kids with diabetes emergency
- New nursing checklist speeds recovery for kids with diabetic crisis