None listed
Conditions
Brief summary
Hyperkalaemia is a potentially life-threatening condition caused by high blood potassium levels. It is commonly treated with insulin and glucose, but insulin can lower blood sugar too much, leading to hypoglycaemia—a condition that can cause confusion, shakiness, or even loss of consciousness. We want to find out whether glucose alone, without insulin, can safely and effectively lower potassium levels in people without diabetes. This may be possible because glucose stimulates the body to produce its own insulin. We are conducting a clinical trial at the Royal Brisbane and Women’s Hospital Emergency and Trauma Centre to compare standard insulin–glucose therapy with glucose-only treatment. The trial will assess both safety (risk of hypoglycaemia) and effectiveness (potassium reduction). If glucose-only therapy is found to be safer and just as effective, it could change the standard treatment for hyperkalaemia.
Interventions
Glucose-Only Therapy:
10mL (2.2mmol) calcium gluconate intravenously over 2-3 minutes
10mg salbutamol via nebulisation
100 mL (50%) dextrose administered intravenously over 10 minutes, followed by 250 mL (10%) dextrose administered intravenously over 2 hours.
Interventions will be administered by a registered nurse. Staff will be educated on the trial protocol before the first patient is enrolled. Adherence to protocol will be assessed through retrospective chart review.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults (18 years or older), hyperkalaemia (serum or blood gas potassium >5.5 mmol/L), treating ED clinician determines that treatment for hyperkalaemia is necessary and agrees to randomize the patient to one of the treatment arms, ability to provide informed consent or, if the patient lacks capacity, consent obtained from a legally authorised substitute decision-maker.
Exclusion criteria
Diabetes mellitus, pre-treatment blood glucose >7.8 mmol/L, requiring resuscitation, intravenous insulin administered before randomisation, suspected or confirmed intracranial/ intraspinal ischaemic or haemorrhagic stroke, known glucose-galactose malabsorption syndrome, known allergy to corn (maize) and corn products.
Outcome results
None listed