Insulin Dextrose Infusion vs Nebulized Salbutamol vs Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia
InSaKa
InSaKa Trial: Insulin Dextrose Infusion Versus Nebulized Salbutamol Versus Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia: a Randomized Clinical Trial
1 other identifier
interventional
525
1 country
16
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2019
Longer than P75 for phase_4
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedStudy Start
First participant enrolled
December 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2026
ExpectedApril 30, 2024
April 1, 2024
6 years
July 5, 2019
April 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in the absolute serum potassium level from baseline to 60 minutes
The primary outcome of our trial will be mean change in the absolute serum potassium level from baseline to 60 minutes (measured in mmol/l), and will be aggregated using median and interquartile.
60 minutes
Secondary Outcomes (7)
Mean change in the serum potassium level from baseline to 180 minutes and 24 hours
180 minutes and 24 hours
Proportion of patients who had a serum potassium level of 4 mmol/l to less than 4.9 mmol/l at 60, 180 minutes and 24 hours
60 minutes, 180 minutes and 24 hours
Proportion of patients who require re-treatment or dialysis at 60, 180 minutes and 24 hours
60 minutes, 180 minutes and 24 hours
Proportion of patients with adverse effects at 60 and 180 minutes
60 minutes and 180 minutes
Proportion of patients with heart rhythm disorders or high grade atrioventricular bloc that required urgent medication during the first 180 minutes
180 minutes
- +2 more secondary outcomes
Study Arms (3)
Salbutamol
EXPERIMENTALPatients in this experimental group will receive : 10 mg of salbutamol nebulized in 30 minutes (with oxygen 8 liters per minute or with air);
Insuline + dextrose
ACTIVE COMPARATORPatients in the experimental group will receive : 10 units of regular insulin (rapid-acting, insuline asparte, intravenous injection) as an intravenous bolus with 500 ml of 10% dextrose in water administered over a 30-minute period
Insuline + Dextrose + Salbutamol
EXPERIMENTALPatients in the experimental group will receive either: 1. 10 mg of salbutamol nebulized in 30 minutes (with oxygen 8 liters per minute or with air); OR 2. 10 units of regular insulin (rapid-acting, insuline asparte, intravenous injection) as an intravenous bolus with 500 ml of 10% dextrose in water administered over a 30-minute period plus 10 mg of salbutamol nebulized in 30 minutes (with oxygen 8 liters per minute or with air). The nurse will start by giving the 10 units of insulin and the dextrose, and then, immediately, she will start the nebulization of salbutamol.
Interventions
10 mg of salbutamol nebulized in 30 minutes (with oxygen 8 liters per minute or with air) 10 units of regular insulin (rapid-acting, insuline asparte, intravenous injection) as an intravenous bolus with 500 ml of 10% dextrose in water administered over a 30-minute period.
Patients in the experimental group will receive either: 1. 10 mg of salbutamol nebulized in 30 minutes (with oxygen 8 liters per minute or with air); OR 2. 10 units of regular insulin (rapid-acting, insuline asparte, intravenous injection) as an intravenous bolus with 500 ml of 10% dextrose in water administered over a 30-minute period plus 10 mg of salbutamol nebulized in 30 minutes (with oxygen 8 liters per minute or with air). The nurse will start by giving the 10 units of insulin and the dextrose, and then, immediately, she will start the nebulization of salbutamol.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Agen Hospital
Agen, France
Angers University Hospital
Angers, France
Avicenne University Hospital
Bobigny, France
University Hospital, Clermont-Ferrand
Clermont-Ferrand, France
Louis Mourier Hospital
Colombes, France
University Hospital, Grenoble
Grenoble, France
Nancy University Hospital
Nancy, France
Nantes University Hospital
Nantes, France
Nice University Hospital
Nice, France
La Pitié Salpêtrière University Hospital
Paris, France
Lariboisiere Hospital
Paris, France
Saint Antoine University Hospital
Paris, France
Poitiers University Hospital
Poitiers, France
Rennes University Hospital
Rennes, France
Strasbourg University Hospital
Strasbourg, France
Tours University Hospital
Tours, France
Related Publications (1)
Montassier E, Lemoine L, Hardouin JB, Rossignol P, Legrand M. Insulin glucose infusion versus nebulised salbutamol versus combination of salbutamol and insulin glucose in acute hyperkalaemia in the emergency room: protocol for a randomised, multicentre, controlled study (INSAKA). BMJ Open. 2020 Aug 26;10(8):e039277. doi: 10.1136/bmjopen-2020-039277.
PMID: 32847923DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie CONTENTI
Nice University Hopsital
- PRINCIPAL INVESTIGATOR
Pierre-Clément THIEBAUD
Saint Antoine University Hospital
- PRINCIPAL INVESTIGATOR
Maxime MAIGNAN
University Hospital, Grenoble
- PRINCIPAL INVESTIGATOR
Jeannot SCHMIDT
University Hospital, Clermont-Ferrand
- PRINCIPAL INVESTIGATOR
Meïssa KARE
Agen Hospital
- PRINCIPAL INVESTIGATOR
Tahar CHOUIHED
Central Hospital, Nancy, France
- PRINCIPAL INVESTIGATOR
Anne-Laure FERAL-PIERSSENS
Avicenne University Hospital
- PRINCIPAL INVESTIGATOR
Florent MAILLET
Louis Mourier Hospital
- PRINCIPAL INVESTIGATOR
Quentin DELANNOY
La Pitié Salpetrière University Hospital
- PRINCIPAL INVESTIGATOR
Nicolas MARJANOVIC
Poitiers University Hospital
- PRINCIPAL INVESTIGATOR
delphine DOUILLET
Angers University Hospital
- PRINCIPAL INVESTIGATOR
Paul-Louis MARTIN
Tours University Hospital
- PRINCIPAL INVESTIGATOR
Pierrick LE BORGNE
University Hospital, Strasbourg, France
- PRINCIPAL INVESTIGATOR
Xavier EYER
Lariboisière Hospital
- PRINCIPAL INVESTIGATOR
Nicolas PESCHANSKI
Rennes University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2019
First Posted
July 9, 2019
Study Start
December 20, 2019
Primary Completion
December 20, 2025
Study Completion (Estimated)
June 20, 2026
Last Updated
April 30, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Access Criteria
- the dataset can be obtained from the corresponding author on reasonable request
Trial data are not publicly available owing to data privacy, but access to the anonymised dataset can be obtained from the corresponding author on reasonable request.