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Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis

NCT05752279 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2025-09-17

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Plasma-Lyte 148

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

DRUG

0.9% sodium chloride

0.9% sodium chloride intravenous fluid for resuscitation in patients with keto-acidosis

Sponsors & Collaborators

  • The George Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-14
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05752279 on ClinicalTrials.gov