Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05752279




Registration number
NCT05752279
Ethics application status
Date submitted
7/02/2023
Date registered
2/03/2023
Date last updated
18/01/2024

Titles & IDs
Public title
Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis
Scientific title
Balanced Multi-electrolyte Solution Versus 0.9% Sodium Chloride as Fluid Therapy for Patients Presenting With Moderate to Severe Diabetic Ketoacidosis
Secondary ID [1] 0 0
TGI CCP-2378-352
Universal Trial Number (UTN)
Trial acronym
BEST-DKA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Ketoacidosis 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Plasma-Lyte 148
Treatment: Drugs - 0.9% sodium chloride

Active Comparator: Plasma-Lyte® 148 - Plasma-Lyte® 148 fluid 1L given intravenously for fluid replacement

Active Comparator: 0.9% sodium chloride - Normal saline fluid 1L given intravenously for fluid replacement


Treatment: Drugs: Plasma-Lyte 148
Plasma-Lyte® 148 intravenous fluid for resuscitation in patients with keto-acidosis

Treatment: Drugs: 0.9% sodium chloride
0.9% sodium chloride intravenous fluid for resuscitation in patients with keto-acidosis
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hospital free days (HFD) up to day-28 after study enrolment
Timepoint [1] 0 0
from time of enrolment to 28 days
Secondary outcome [1] 0 0
ICU free days up to 28 days after study enrolment
Timepoint [1] 0 0
28 days after enrolment
Secondary outcome [2] 0 0
ICU and hospital readmissions up to 28 days after study enrolment
Timepoint [2] 0 0
28 days after enrolment
Secondary outcome [3] 0 0
Acute kidney injury assessed by comparing serum creatinine using Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Timepoint [3] 0 0
28 days after enrolment
Secondary outcome [4] 0 0
Episodes of post-study enrolment decrease in Glasgow Coma Scale (GCS) by more than 2 in the first 24 hours
Timepoint [4] 0 0
first 24 hours from enrolment
Secondary outcome [5] 0 0
Time to resolution of ketosis
Timepoint [5] 0 0
from time of enrolment to day 28
Secondary outcome [6] 0 0
Cumulative insulin dosage in the first 48 hours
Timepoint [6] 0 0
first 48 hours from time of enrolment
Secondary outcome [7] 0 0
Duration of IV insulin infusion
Timepoint [7] 0 0
from time of enrolment to day 28
Secondary outcome [8] 0 0
Cumulative potassium replacement
Timepoint [8] 0 0
from time of enrolment to day 28

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
680
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 0 0
Redcliffe Hospital - Redcliffe
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4020 - Redcliffe

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT05752279
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05752279