None listed
Conditions
Brief summary
This is a cluster crossover trial to determine whether fluid therapy with a buffered salt solution (Plasmalyte-148) reduces the time to resolution of acidosis compared to 0.9% sodium chloride (saline) in critically ill patients presenting to the emergency department with diabetic ketoacidosis (DKA). • We hypothesise that the use of PL as fluid therapy in these patients will lead to earlier resolution of acidosis and avoidance of hyperchloraemia, thereby reducing morbidity and length of stay
Interventions
Two different types of intravenous fluid will be compared in this trial:
1. 0.9% Sodium Chloride
2. Buffered salt solution (for the purpose of this trial, the buffered salt solution that will be used is Plasma-lyte 148)
The mode of administration will be intravenous via either a peripheral intravenous cannula or a central venous catheter. The dosage will be at the discretion of the treating physician.
There will be two intervention periods of 6 months each, separated by a 1 month washout betw
Two different types of intravenous fluid will be compared in this trial: 1. 0.9% Sodium Chloride 2. Buffered salt solution (for the purpose of this trial, the buffered salt solution that will be used is Plasma-lyte 148) The mode of administration will be intravenous via either a peripheral intravenous cannula or a central venous catheter. The dosage will be at the discretion of the treating physician. There will be two intervention periods of 6 months each, separated by a 1 month washout between these two periods. All participating sites will be randomised to either 0.9% saline or Plasma-lyte 148 for the first 6 month period during which all patients admitted with DKA will will be treated with the assigned fluid for the first 48 hours of ICU admission at each site. Following the first 6 month period and the 1 month washout, all sites will crossover to the other fluid for the next 6 month period.
Sponsors
Trial Management Committee
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients greater than or equal to 16 years of age, admitted to the emergency department at participating sites with a diagnosis of diabetic ketoacidosis, which was defined as: • Blood glucose level greater than 14 mmol/L AND • pH less than 7.25 OR serum bicarbonate less than 15 mmol/L AND • ICU admission required in the judgement of the treating clinician
Exclusion criteria
• Age less than 16 • Serum potassium greater than 6.5 mmol/L prior to randomisation • Patients with hyperosmotic hyperglycaemic, non-ketotic syndrome • Patients who have previously been included in this trial
Outcome results
None listed