Status:
RECRUITING
Insulin Dextrose Infusion vs Nebulized Salbutamol vs Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia
Lead Sponsor:
Nantes University Hospital
Conditions:
Hyperkalemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Hyperkalemia is a common electrolyte disorder, especially among patients with chronic kidney disease, diabetes mellitus, or heart failure. Globally, the reported incidence of hyperkalemia varies from ...
Detailed Description
InSaKa trial is a therapeutic, controlled, open label, with parallel groups of treatment in a 1:1:1 ratio, multi-centre, national and randomized clinical trial to compare insulin/dextrose intravenous ...
Eligibility Criteria
Inclusion
- Patient older than 18 years old
- Patient admitted to the emergency department,
- Patient with 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
Exclusion
- Hemolysis or thrombocytosis \> 106/mm3 or hyperleukocytosis \> 105/mm3 on the first blood sample suspecting a pseudohyperkalemia,
- Diabetic ketoacidosis or 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, diuretics or bicarbonate within the first 60 minutes,
- Patient with heart rhythm disorders or high grade atrioventricular bloc who require urgent medication as soon as admission or serum potassium level result,
- Hypersensitivity to the tested active substance or excipients,
- Acute coronary syndrome,
- Patient not affiliated to a health insurance plan,
- Patient under guardianship, curatorship or safeguard of justice.
- The contraceptives considered as highly effective and acceptable by CTFG recommendations will be considered effective under this protocol. The list of contraceptives considered as highly effective and acceptable by CTFG recommendations is detailed in Appendix 7
Key Trial Info
Start Date :
December 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 20 2026
Estimated Enrollment :
525 Patients enrolled
Trial Details
Trial ID
NCT04012138
Start Date
December 20 2019
End Date
June 20 2026
Last Update
April 30 2024
Active Locations (16)
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1
Agen Hospital
Agen, France
2
Angers University Hospital
Angers, France
3
Avicenne University Hospital
Bobigny, France
4
University Hospital, Clermont-Ferrand
Clermont-Ferrand, France