Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis
BEST-DKA
Balanced Multi-electrolyte Solution Versus 0.9% Sodium Chloride as Fluid Therapy for Patients Presenting With Moderate to Severe Diabetic Ketoacidosis
1 other identifier
interventional
680
1 country
21
Brief Summary
The goal of this blinded, cluster cross-over, randomised controlled trial is to determine whether fluid therapy with Plasma-Lyte® 148 increases the number of days alive and days out of hospital to day-28 compared to 0.9% sodium chloride ('0.9% saline') in critically ill patients presenting to the Emergency Department (ED) and deemed to require admission to a critical care area (ICU, HDU) with moderate to severe diabetic ketoacidosis (DKA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2024
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2023
CompletedFirst Posted
Study publicly available on registry
March 2, 2023
CompletedStudy Start
First participant enrolled
March 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
September 17, 2025
September 1, 2025
2.3 years
February 7, 2023
September 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Hospital free days (HFD) up to day-28 after study enrolment
Number of hospital free days from time of hospital discharge
from time of enrolment to 28 days
Secondary Outcomes (8)
ICU free days up to 28 days after study enrolment
28 days after enrolment
ICU and hospital readmissions up to 28 days after study enrolment
28 days after enrolment
Acute kidney injury assessed by comparing serum creatinine using Kidney Disease: Improving Global Outcomes (KDIGO) criteria
28 days after enrolment
Episodes of post-study enrolment decrease in Glasgow Coma Scale (GCS) by more than 2 in the first 24 hours
first 24 hours from enrolment
Time to resolution of ketosis
from time of enrolment to day 28
- +3 more secondary outcomes
Other Outcomes (1)
Cost-effectiveness
from time of enrolment to day 28
Study Arms (2)
Plasma-Lyte® 148
ACTIVE COMPARATORPlasma-Lyte® 148 fluid 1L given intravenously for fluid replacement
0.9% sodium chloride
ACTIVE COMPARATORNormal saline fluid 1L given intravenously for fluid replacement
Interventions
Plasma-Lyte® 148 intravenous fluid for resuscitation in patients with keto-acidosis
0.9% sodium chloride intravenous fluid for resuscitation in patients with keto-acidosis
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Blacktown Hospital
Blacktown, New South Wales, 2148, Australia
Camperdown Hospital
Camperdown, New South Wales, 2050, Australia
Dubbo Base Hospital
Dubbo, New South Wales, 2830, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Maitland Hospital
Metford, New South Wales, 2323, Australia
Orange Hospital
Orange, New South Wales, 2800, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Caboolture Hospital
Caboolture, Queensland, Australia
Queen Elizabeth II Jubilee Hospital
Coopers Plains, Queensland, 4108, Australia
Redcliffe Hospital
Redcliffe, Queensland, 4020, Australia
Rockhampton Hospital
Rockhampton, Queensland, 4700, Australia
Gold Coast University Hospital
Southport, Queensland, 4215, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Ballarat Base Hospital
Ballarat, Victoria, 3350, Australia
Monash Health-Casey Hospital
Berwick, Victoria, 3806, Australia
Dandenong Hospital
Dandenong, Victoria, 3175, Australia
Frankston Hospital - Peninsula Health
Frankston, Victoria, 3199, Australia
Latrobe Regional Hospital
Traralgon, Victoria, 3844, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2023
First Posted
March 2, 2023
Study Start
March 14, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
September 17, 2025
Record last verified: 2025-09