Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT04012138 En recrutement IDF

Titre

InSaKa Trial: Insulin Dextrose Infusion Versus Nebulized Salbutamol Versus Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia: a Randomized Clinical Trial (InSaKa)

Type

Interventional

Pathologie

Hyperkaliémie

Phase

Phase 4

Promoteur

Nantes University Hospital (Voir sur ClinicalTrials)

Date de début

décembre 2019

Date de fin

juin 2026

Dernière mise à jour

29 juin 2024

Résumé

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 1.1 to 10 per 100 hospitalizations, depending on the patient cohort and comorbidities. Hyperkalemia is a potentially life-threatening electrolyte disturbance that can be fatal if left untreated. Several studies have established the association between hyperkalemia and all-cause mortality. Because of the deleterious cardiac effects of hyperkalemia, its management is an emergency intervention. However, robust evidence is lacking to guide the emergency management of patients with hyperkalemia. Emergency treatment approaches are largely based on small studies, anecdotal experience, and traditionally accepted practice patterns within institutions. Therefore, a rigorous evaluation of the first-line treatments of hyperkalemia in emergency departments is needed and a large scale randomized clinical trial is warranted before robust recommendations for clinical practice can be made. Our clinical trial will improve the safety of patients with acute hyperkalemia and will help clinicians in their day by day practice to choose the treatment that significantly reduces morbidity and mortality during acute hyperkalemia management. Our results will be delivered in a timely fashion, owing to the high prevalence of hyperkalemia in the emergency department setting and to the commitment of the INI-CRCT network of Excellence, along with ED specialists used to work jointly. the primary objective of our trial is 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.

Détail

Voir le détail 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 infusion, nebulized salbutamol or combination of salbutamol and insulin/dextrose to reduce serum potassium levels at 60 minutes. Eligible patients will be recruited in the emergency department and included in the study after testing for inclusion and non-inclusion criteria. Patients will be eligible for the randomization if they had a serum potassium concentration superior or equal to 6 mmol per liter. Randomization, which will be performed centrally, will be stratified 1) according to the serum potassium level at baseline of the initial treatment phase (6 to < 6.5 mmol per liter [moderate hyperkalemia] AND superior or equal to 6.5 mmol per liter [severe hyperkalemia]), and 2) according to the prescription or not of intravenous diuretics during the 6 previous hours. The protocol will be approved by the ethical committee (random allocation) of the IRB. All patients will provide written informed consent and the study will be performed in accordance with the International Conference on Harmonization Guidelines for Good Clinical Practice. All electrocardiograms will be read at a core electrocardiographic laboratory. At the time of screening, patients who meet all the inclusion and do not have non-inclusion criteria will be assigned to one of the 3 groups of treatment. The serum potassium will be then measured at 60 minutes. If the patient still has hyperkalemia at 60 minutes, the patient will be re-administered a treatment, left at the discretion of the physician in charge. This treatment might include insulin/dextrose intravenous infusion, nebulized salbutamol, the combination of nebulized salbutamol and insulin/dextrose intravenous infusion, bicarbonate, diuretics or dialysis. Especially, bicarbonate should be prescribed in case of metabolic acidosis or hypovolemic shock, and diuretics in case of acute heart failure. Importantly, if the patient has a major cardiovascular event before 60 minutes, all these treatments might be prescribed at the discretion of the physician in charge, if the clinical situation requires one or more of these therapeutic options, and based on up-to-date clinical practice guidelines and recommendations. Serum potassium levels will be measured at local laboratories at baseline and 60, 180 minutes and 24 hours. They will perform a visual inspection and a validated semi-quantitative test on each blood sample as an assessment for hemolysis. An independent adjudication committee will adjudicate all major cardiovascular events. The trial will be monitored by a Data Safety Monitoring Board. Fermer le détail

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Avicenne		Active, sans recrutement	Contact (sur clinicalTrials)
AP-HP - Hôpital Lariboisiere-Fernand Widal	Xavier EYER	En recrutement IDF	Contact (sur clinicalTrials)
AP-HP - Hôpital Louis Mourier		Active, sans recrutement	Contact (sur clinicalTrials)
AP-HP - Hôpital Saint Antoine	Pierre-Clément THIEBAUD	En recrutement IDF	Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Angers University Hospital - Angers - France	Delphine DOUILLET	En recrutement	Contact (sur clinicalTrials)
Nancy University Hospital - Nancy - France	Tahar CHOUIHED	En recrutement	Contact (sur clinicalTrials)
Poitiers University Hospital - Poitiers - France	Olivier MIMOZ	En recrutement	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Agen Hospital - Agen - France	Albert TRINC DUC	En recrutement	Contact (sur clinicalTrials)
La Pitié Salpêtrière University Hospital - Paris - France	Yonathan FREUND	En recrutement	Contact (sur clinicalTrials)
Nantes University Hospital - Nantes - France	Emmanuel Montassier	En recrutement	Contact (sur clinicalTrials)
Nice University Hospital - Nice - France		Active, sans recrutement	Contact (sur clinicalTrials)
Rennes University Hospital - Rennes - France	Nicolas Peschanski, PhD	En recrutement	Contact (sur clinicalTrials)
Strasbourg University Hospital - Strasbourg - France		Active, sans recrutement	Contact (sur clinicalTrials)
Tours University Hospital - Tours - France	Paul-Louis MARTIN	En recrutement	Contact (sur clinicalTrials)
University Hospital, Clermont-Ferrand - Clermont-Ferrand - France	Jeannot SCHMIDT	En recrutement	Contact (sur clinicalTrials)
University Hospital, Grenoble - Grenoble - France	Maxime MAIGNAN	En recrutement	Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

- 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

NCT04012138 - InSaKa Trial: Insulin Dextrose Infusion Versus Nebulized Salbutamol Versus Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia: a Randomized Clinical Trial (InSaKa)

Informations générales
Etablissements
Critères
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