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InSaKa trial: Insulin dextrose infusion versus nebulized salbutamol versus combination of salbutamol and insulin dextrose in acute hyperkalemia: a randomized clinical trial
EU CTIS ID: 2024-514889-40-00
What this study is testing
to compare insulin/dextrose intravenous infusion, nebulized salbutamol or combination of nebulized salbutamol and insulin/dextrose intravenous infusion to reduce serum potassium concentration at 60 minutes, as first-line treatment, in emergency departments.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.