Insulin Dextrose Infusion vs Nebulized Salbutamol vs Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia
Launched by NANTES UNIVERSITY HOSPITAL · Jul 5, 2019
Trial Information
Current as of April 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating how well different treatments work for patients with a serious condition called hyperkalemia, which is when there is too much potassium in the blood. This condition can be particularly dangerous and is often seen in people with kidney disease, diabetes, or heart problems. The trial will compare three treatment methods: an infusion of insulin and dextrose (a type of sugar), nebulized salbutamol (a medication often used for asthma), or a combination of both. The goal is to see which treatment most effectively lowers potassium levels within 60 minutes in emergency department patients.
To participate in this trial, you need to be over 18 years old and admitted to the emergency department with a potassium level of 5.5 mmol/L or higher. However, certain conditions, like pregnancy or needing immediate dialysis, may prevent you from joining. If you decide to participate, you'll receive one of the treatments being tested, and your potassium levels will be closely monitored. The results from this study aim to help doctors choose the best treatment for hyperkalemia in emergency situations, ultimately improving patient safety and outcomes.
Gender
ALL
Eligibility 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
About Nantes University Hospital
Nantes University Hospital, a leading academic medical institution in France, is dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific exploration with patient care, fostering collaborations among multidisciplinary teams of healthcare professionals and researchers. With a strong emphasis on ethical standards and patient safety, Nantes University Hospital aims to contribute to the development of effective therapies and interventions that enhance patient outcomes and overall public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nantes, , France
Rennes, , France
Tours, , France
Angers, , France
Poitiers, , France
Paris, , France
Grenoble, , France
Colombes, , France
Clermont Ferrand, , France
Strasbourg, , France
Nice, , France
Nancy, , France
Agen, , France
Bobigny, , France
Paris, , France
Paris, , France
Patients applied
Trial Officials
Julie CONTENTI
Principal Investigator
Nice University Hopsital
Pierre-Clément THIEBAUD
Principal Investigator
Saint Antoine University Hospital
Maxime MAIGNAN
Principal Investigator
University Hospital, Grenoble
Jeannot SCHMIDT
Principal Investigator
University Hospital, Clermont-Ferrand
Meïssa KARE
Principal Investigator
Agen Hospital
Tahar CHOUIHED
Principal Investigator
Central Hospital, Nancy, France
Anne-Laure FERAL-PIERSSENS
Principal Investigator
Avicenne University Hospital
Florent MAILLET
Principal Investigator
Louis Mourier Hospital
Quentin DELANNOY
Principal Investigator
La Pitié Salpetrière University Hospital
Nicolas MARJANOVIC
Principal Investigator
Poitiers University Hospital
delphine DOUILLET
Principal Investigator
Angers University Hospital
Paul-Louis MARTIN
Principal Investigator
Tours University Hospital
Pierrick LE BORGNE
Principal Investigator
University Hospital, Strasbourg, France
Xavier EYER
Principal Investigator
Lariboisière Hospital
Nicolas PESCHANSKI
Principal Investigator
Rennes University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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