Evidence map›Paper›PMID 40160240›Full record

ArticleCritical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine2025

Buffered salt solution versus 0.9% sodium chloride as fluid therapy for patients presenting with moderate to severe diabetic ketoacidosis: Study protocol for a Phase-3 cluster-crossover, blinded, randomised, controlled trial.

Mahesh Ramanan, Dorrilyn Rajbhandari, Carolyn Koch, Yasmine Ali Abdelhamid, Antony Attokaran, Laurent Billot, Severine Bompoint, Jeremy Cohen, Anthony Delaney, Anthony Devaux and 15 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Mahesh RamananIntensive Care Services, Caboolture and Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
Dorrilyn RajbhandariCritical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Carolyn KochCritical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Yasmine Ali AbdelhamidIntensive Care Unit, Royal Melbourne Hospital, Parkville, Victoria, Australia.
Antony AttokaranIntensive Care Unit, Rockhampton Hospital, Rockhampton, Queensland, Australia.
Laurent BillotStatistics Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Severine BompointThe George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Jeremy CohenThe George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Anthony DelaneyCritical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Anthony DevauxThe George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Elif EkinciMelbourne Medical School, University of Melbourne, Parkville, Victoria, Australia.
Simon FinferCritical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Tessa GarsideIntensive Care Department, Royal North Shore Hospital, St Leonards, New South Wales, Australia.
Naomi HammondCritical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Alisa HigginsCritical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Gerben KeijzersEmergency Department, Gold Coast University Hospital, Gold Coast, Australia.
Qiang LiThe George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Benjamin MoranCritical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
John MyburghCritical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Priya NairIntensive Care Services, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
Sandra PeakeIntensive Care Unit, The Queen Elizabeth Hospital, Woodville, South Australia, Australia.
Anthony RussellSchool of Public Health and Preventative Medicine, Monash University, Clayton, Victoria, Australia.
Alexis TabahFaculty of Health, Queensland University of Technology, Brisbane, Queensland, Australia.
Stacey WattsDepartment of Emergency Medicine, Caboolture Hospital, Caboolture, Queensland, Australia.
Balasubramanian VenkateshCritical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The optimal choice of fluid therapy for patients with diabetic ketoacidosis (DKA) is uncertain, though preliminary data suggest that buffered crystalloid solutions (Plasma-Lyte® 148) may offer some advantages over 0.9% saline. Objective: To describe the study protocol for the 'Balanced Electrolyte Solution versus Saline Trial for Diabetic Ketoacidosis' (BEST-DKA) trial. Design setting and participants: BEST-DKA is a Phase 3 cluster-crossover, blinded, pragmatic, randomised, controlled trial comparing the effects of saline or buffered crystalloid solution in patients with moderate to severe DKA treated in the emergency department and/or intensive care unit at twenty hospitals in Australia. Each hospital will be randomised to use either saline or buffered crystalloid solution for a period of 12 months before crossing over to the alternate fluid for the next 12 months. The blinded study fluid will be used for all resuscitation and maintenance purposes for included patients. Main outcome measures: This cluster-randomised, crossover randomised controlled trial (RCT) has been designed with the aim of enrolling a minimum of 400 patients, which will provide >91.4% power to detect a 2-day increase in the primary outcome, days alive and out of hospital to day 28, chosen with consumer representation. Secondary outcomes include quality of life and fatigue scores at day 28, intensive care unit and hospital lengths of stay, acute kidney injury, and time to resolution of DKA. All analyses will be conducted on an intention-to-treat basis. A prespecified statistical analysis plan will be developed prior to interim analysis. Results and conclusion: The BEST-DKA trial commenced enrolment in March 2024 and should generate results that will determine whether treatment with Plasma-Lyte® 148, compared with saline, results in increased days alive, and out of hospital to day 28 for patients with moderate or severe DKA.

Indexed as

Critical careDiabetesDiabetic ketoacidosisEmergencyFluid

Identifiers

PMID40160240
PMCPMC11952770

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.