Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05752279
PHASE3

Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis

Sponsor: The George Institute

View on ClinicalTrials.gov

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).

Official title: Balanced Multi-electrolyte Solution Versus 0.9% Sodium Chloride as Fluid Therapy for Patients Presenting With Moderate to Severe Diabetic Ketoacidosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

680

Start Date

2024-03-14

Completion Date

2026-07

Last Updated

2025-09-17

Healthy Volunteers

No

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

Locations (21)

Blacktown Hospital

Blacktown, New South Wales, Australia

Camperdown Hospital

Camperdown, New South Wales, Australia

Dubbo Base Hospital

Dubbo, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

Maitland Hospital

Metford, New South Wales, Australia

Orange Hospital

Orange, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Caboolture Hospital

Caboolture, Queensland, Australia

Queen Elizabeth II Jubilee Hospital

Coopers Plains, Queensland, Australia

Redcliffe Hospital

Redcliffe, Queensland, Australia

Rockhampton Hospital

Rockhampton, Queensland, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Ballarat Base Hospital

Ballarat, Victoria, Australia

Monash Health-Casey Hospital

Berwick, Victoria, Australia

Dandenong Hospital

Dandenong, Victoria, Australia

Frankston Hospital - Peninsula Health

Frankston, Victoria, Australia

Latrobe Regional Hospital

Traralgon, Victoria, Australia