RecruitingPhase 3NCT05752279

Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis

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


Sponsor

The George Institute

Enrollment

680 participants

Start Date

Mar 14, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 0.9% sodium chloride and a drug called Plasma-Lyte 148 for people with diabetic ketoacidosis. The study is currently recruiting participants at 21 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlasma-Lyte 148

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

DRUG0.9% 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

View Full Details on ClinicalTrials.gov

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NCT05752279


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