InSaKa trial: Insulin dextrose infusion versus nebulized salbutamol versus combination of salbutamol and insulin dextrose in acute hyperkalemia: a randomized clinical trial
- Conditions
- HyperkalemiaTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- CTIS2024-514889-40-00
- Lead Sponsor
- Centre Hospitalier Universitaire De Nantes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 525
Patient older than 18-year old, Patient admitted to the emergency department, Local laboratory serum potassium level superior or equal to 5,5 mmol/l, Patient who provide written informed consent prior to participation in the study
Hemolysis of blood samples or thrombocytosis > 106/mm3 or hyperleukocytosis > 105/mm3 on the first blood sample suspecting a pseudohyperkalemia, Acute coronary syndrome, Patient not affiliated to a health insurance plan, Patient under guardianship, curatorship or safeguard of justice, Acute complications of diabetes: diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome, Pregnant or lactating woman, women with childbearing potential who didn’t have effective contraception., Patient expected to require emergency intubation and ventilation, Patient expected to require dialysis within the first 60 minutes, Patient expected to require diuretics within the first 60 minutes, Patient expected to require bicarbonate within the first 60 minutes, Patient with heart rhythm disorders or high grade atrioventricular bloc that require urgent medication as soon as admission or serum potassium level result, Hypersensitivity to the tested active substance or to the excipients of salbutamol or insulin treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method