Comparing treatments for high potassium levels in emergency patients
InSaKa Trial: Insulin Dextrose Infusion Versus Nebulized Salbutamol Versus Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia: a Randomized Clinical Trial
This study is testing three different treatments for high potassium levels in emergency patients to see which one works best to lower those levels quickly.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 525 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 16 sites (Agen and 15 other locations) |
| Trial ID | NCT04012138 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of three different treatments for acute hyperkalemia: intravenous insulin/dextrose infusion, nebulized salbutamol, and a combination of both. It is a multi-centre, randomized, controlled trial where eligible patients with elevated serum potassium levels will be assigned to one of the treatment groups. The primary outcome is the reduction of serum potassium levels within 60 minutes of treatment. The study aims to provide robust evidence to guide emergency management of hyperkalemia, a potentially life-threatening condition.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old admitted to the emergency department with serum potassium levels of 6 mmol/L or higher.
Not a fit: Patients with conditions requiring immediate intervention, such as severe heart rhythm disorders or those needing dialysis within the first hour, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective emergency treatments for patients with high potassium levels, potentially reducing mortality and morbidity.
How similar studies have performed: While there is limited robust evidence for the emergency management of hyperkalemia, previous studies have explored similar treatment approaches, indicating a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Agen and 15 other locations
- Agen Hospital — Agen, France (Recruiting)
- Angers University Hospital — Angers, France (Recruiting)
- Avicenne University Hospital — Bobigny, France (Active_not_recruiting)
- University Hospital, Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- Louis Mourier Hospital — Colombes, France (Active_not_recruiting)
- University Hospital, Grenoble — Grenoble, France (Recruiting)
- Nancy University Hospital — Nancy, France (Recruiting)
- Nantes University Hospital — Nantes, France (Recruiting)
- Nice University Hospital — Nice, France (Active_not_recruiting)
- La Pitié Salpêtrière University Hospital — Paris, France (Recruiting)
- Lariboisiere Hospital — Paris, France (Recruiting)
- Saint Antoine University Hospital — Paris, France (Recruiting)
- Poitiers University Hospital — Poitiers, France (Recruiting)
- Rennes University Hospital — Rennes, France (Recruiting)
- Strasbourg University Hospital — Strasbourg, France (Active_not_recruiting)
- Tours University Hospital — Tours, France (Recruiting)
Study contacts
- Principal investigator: Julie CONTENTI — Nice University Hopsital
- Study coordinator: Emmanuel MONTASSIER
- Email: emmanuel.montassier@chu-nantes.fr
- Phone: 02 53 48 20 38
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.