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Search / Trial NCT04012138

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

Hyperkaliema Insulin Salbutamol

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.

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

0 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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