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

IF 1.4 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation Pub Date : 2025-03-01 DOI:10.1016/j.ccrj.2025.100104

Mahesh Ramanan FCICM, MMed , Dorrilyn Rajbhandari PGDip Clin Nurs , Carolyn Koch RN PGDip ICU , Yasmine Ali Abdelhamid FCICM, FRACP, PhD , Antony Attokaran FCICM, FRACP, MBBS , Laurent Billot AStat, MRes , Severine Bompoint AStat , Jeremy Cohen FCICM, PhD , Anthony Delaney FCICM, FACEM, PhD , Anthony Devaux PhD , Elif Ekinci FRACP, PhD , Simon Finfer FCICM, DrMed , Tessa Garside FCICM, PhD , Naomi Hammond RN, PhD , Alisa Higgins PhD , Gerben Keijzers FACEM, PhD , Qiang Li AStat, MBiostat , Benjamin Moran FCICM, FANZCA, MBiostat , John Myburgh FCICM, PhD , Priya Nair FCICM, PhD , Balasubramanian Venkatesh FCICM, MD

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引用次数: 0

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.

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来源期刊

Critical Care and Resuscitation CRITICAL CARE MEDICINE-

CiteScore

7.70

自引率

3.40%

发文量

审稿时长

>12 weeks

期刊介绍： ritical Care and Resuscitation (CC&R) is the official scientific journal of the College of Intensive Care Medicine (CICM). The Journal is a quarterly publication (ISSN 1441-2772) with original articles of scientific and clinical interest in the specialities of Critical Care, Intensive Care, Anaesthesia, Emergency Medicine and related disciplines. The Journal is received by all Fellows and trainees, along with an increasing number of subscribers from around the world. The CC&R Journal currently has an impact factor of 3.3, placing it in 8th position in world critical care journals and in first position in the world outside the USA and Europe.