Find Diabetic Ketoacidosis Clinical Trials Near You
Balanced Multi-electrolyte Solution Versus 0.9% Sodium Chloride as Fluid Therapy for Patients Presenting With Moderate to Severe Diabetic Ketoacidosis
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients in the ED with a primary diagnosis of moderate to severe DKA for whom both saline and Plasma-Lyte® 148 are considered appropriate fluids
• Blood glucose level \> 14mmol/L
• pH \< 7.25
• Serum bicarbonate \<15 mmol/L
• Elevated anion gap \> 12mEq/L
• Ketones positive on finger prick measurements
• In the judgement of the treating clinician critical care area admission is required
Locations
Other Locations
Australia
Ballarat Base Hospital
RECRUITING
Ballarat
Monash Health-Casey Hospital
RECRUITING
Berwick
Sunshine Coast University Hospital
RECRUITING
Birtinya
Blacktown Hospital
RECRUITING
Blacktown
Caboolture Hospital
RECRUITING
Caboolture
Camperdown Hospital
RECRUITING
Camperdown
Queen Elizabeth II Jubilee Hospital
RECRUITING
Coopers Plains
Dandenong Hospital
RECRUITING
Dandenong
Dubbo Base Hospital
RECRUITING
Dubbo
Lyell McEwin Hospital
RECRUITING
Elizabeth Vale
Frankston Hospital - Peninsula Health
RECRUITING
Frankston
St George Hospital
RECRUITING
Kogarah
Maitland Hospital
RECRUITING
Metford
Orange Hospital
RECRUITING
Orange
Redcliffe Hospital
RECRUITING
Redcliffe
Rockhampton Hospital
RECRUITING
Rockhampton
Gold Coast University Hospital
RECRUITING
Southport
Royal North Shore Hospital
RECRUITING
St Leonards
Latrobe Regional Hospital
RECRUITING
Traralgon
Westmead Hospital
RECRUITING
Westmead
The Queen Elizabeth Hospital
RECRUITING
Woodville South
Time Frame
Start Date:2024-03-14
Estimated Completion Date:2026-07
Participants
Target number of participants:680
Treatments
Active_comparator: Plasma-Lyte® 148
Plasma-Lyte® 148 fluid 1L given intravenously for fluid replacement
Active_comparator: 0.9% sodium chloride
Normal saline fluid 1L given intravenously for fluid replacement