HyperkalemiaPhase 4InSaKaNCT04012138
Insulin Dextrose Infusion vs Nebulized Salbutamol vs Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia
A Phase 4 study testing Salbutamol and Insulin Aspart in people with Hyperkalemia, run by Nantes University Hospital at 16 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- Salbutamol and Insulin Aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 419 participants
- Where
- 16 sitesFrance
- Study dates
- 20 Dec 2019to 20 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 11Show fewer
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Agen Hospital
Agen
Angers University Hospital
Angers
Avicenne University Hospital
Bobigny
University Hospital, Clermont-Ferrand
Clermont-Ferrand
Louis Mourier Hospital
Colombes
University Hospital, Grenoble
Grenoble
Nancy University Hospital
Nancy
Nantes University Hospital
Nantes
Nice University Hospital
Nice
La Pitié Salpêtrière University Hospital
Paris
Lariboisiere Hospital
Paris
Saint Antoine University Hospital
Paris
Poitiers University Hospital
Poitiers
Rennes University Hospital
Rennes
Strasbourg University Hospital
Strasbourg
Tours University Hospital
Tours
About this study
Official title: InSaKa Trial: Insulin Dextrose Infusion Versus Nebulized Salbutamol Versus Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia: a Randomized Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Hyperkalemia
- Being tested
- Salbutamol, Insulin Aspart
- Keywords
- hyperkaliema, insulin, salbutamol
- Medical subject headings
- Hyperkalemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalbutamolDrug
Also called Salbutamol and Hyperkaliemia
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.
Insulin AspartDrug
Also called Insulin and Hyperkaliemia
Patients in the experimental group will receive either:
- 10 mg of salbutamol nebulized in 30 minutes (with oxygen 8 liters per minute or with air); OR
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Salbutamol | Experimental | Patients in this experimental group will receive : 10 mg of salbutamol nebulized in 30 minutes (with oxygen 8 liters per minute or with air); Receives: Drug: Salbutamol |
| Insuline + dextrose | Active comparator | Patients 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 Receives: Drug: Insulin Aspart |
| Insuline + Dextrose + Salbutamol | Experimental | 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. Receives: Drug: Salbutamol; Drug: Insulin Aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes
Secondary outcomes (7)
Mean change in the serum potassium level from baseline to 180 minutes and 24 hours
Measured: 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
Measured: 60 minutes, 180 minutes and 24 hours
Proportion of patients who require re-treatment or dialysis at 60, 180 minutes and 24 hours
Measured: 60 minutes, 180 minutes and 24 hours
Proportion of patients with adverse effects at 60 and 180 minutes
Proportion of patients with adverse effects at 60 and 180 minutes :
- Hypokalemia (serum potassium level <3.5 mmol/l and <4 mmol/l)
- Hypomagnesemia (serum magnesium level of less than 0.58 mmol per liter)
- Hypoglycemia (serum glucose level < 4.0 mmol/l)
- Hyperglycemia (serum glucose level > 10.0 mmol/l)
- Gastrointestinal disorders:
- Diarrhea ii. Nausea iii. Vomiting f. Tachycardia (> 130/min) g. Tremor
Measured: 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
Measured: 180 minutes
Proportion of patients with electrocardiographic abnormalities, at 60, 180 minutes and 24 hours
Proportion of patients with electrocardiographic abnormalities, at 60, 180 minutes and 24 hours , including:
- Auricular extrasystoles
- Ventricular extrasystoles
- Atrioventricular block
- QRS Interval Prolongation (> 120 ms)
- QT interval prolongation (> 500 ms)
Measured: 60 minutes 180 minutes and 24 hours
Proportion of major cardiovascular events at 60, 180 minutes and 24 hours
Proportion of major cardiovascular events at 60, 180 minutes and 24 hours :
- cardiac arrest
- stroke
- acute heart failure
- complete atrioventricular block with ventricular rate under 30 bpm
- ventricular fibrillation
- ventricular tachycardia
Measured: 60minutes 180 minutes and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start20 Dec 2019
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie CONTENTI, Principal investigator, Nice University HopsitalPierre-Clément THIEBAUD, Principal investigator, Saint Antoine University HospitalMaxime MAIGNAN, Principal investigator, University Hospital, GrenobleJeannot SCHMIDT, Principal investigator, University Hospital, Clermont-FerrandMeïssa KARE, Principal investigator, Agen HospitalTahar CHOUIHED, Principal investigator, Central Hospital, Nancy, FranceAnne-Laure FERAL-PIERSSENS, Principal investigator, Avicenne University HospitalFlorent MAILLET, Principal investigator, Louis Mourier Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012138
- Sponsor's protocol ID
- RC19_0048
- Acronym
- InSaKa
- Status last verified
- May 2026
- First submitted
- 5 Jul 2019
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 32847923
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InSaKa Trial: Insulin Dextrose Infusion Versus Nebulized Salbutamol Versus Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04012138
- Acronym / sponsor ID
- InSaKa / RC19_0048
- Conditions
- Hyperkalemia
- Keywords
- hyperkaliema, insulin, salbutamol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Salbutamol | Experimental | Drug: SalbutamolPatients 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 comparator | Drug: Insulin AspartPatients 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 | Experimental | Drug: Salbutamol, Drug: Insulin AspartPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalbutamolAlso: Salbutamol and Hyperkaliemia10 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. | Drug | Insuline + Dextrose + Salbutamol, Salbutamol |
| Insulin AspartAlso: Insulin and HyperkaliemiaPatients 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. | Drug | Insuline + Dextrose + Salbutamol, Insuline + dextrose |
Primary outcome
Mean change in the absolute serum potassium level from baseline to 60 minutes
Time frame: 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.
7 secondary outcomes
Mean change in the serum potassium level from baseline to 180 minutes and 24 hours
Time frame: 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
Time frame: 60 minutes, 180 minutes and 24 hours
Proportion of patients who require re-treatment or dialysis at 60, 180 minutes and 24 hours
Time frame: 60 minutes, 180 minutes and 24 hours
Proportion of patients with adverse effects at 60 and 180 minutes
Time frame: 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
Time frame: 180 minutes
Proportion of patients with electrocardiographic abnormalities, at 60, 180 minutes and 24 hours
Time frame: 60 minutes 180 minutes and 24 hours
Proportion of major cardiovascular events at 60, 180 minutes and 24 hours
Time frame: 60minutes 180 minutes and 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Derived from this study: PubMed 32847923Montassier 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Hyperkalemia
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
RecruitingPhase 3
A Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
Hyperkalemia
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
Enrolling by invitationPhase 4
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
Chronic Kidney Disease, Type 2 Diabetes
Recruiting
Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie CONTENTI principal investigator
Nice University Hopsital
Pierre-Clément THIEBAUD principal investigator
Saint Antoine University Hospital
Maxime MAIGNAN principal investigator
University Hospital, Grenoble
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salbutamol and Insulin Aspart in people with Hyperkalemia, run by Nantes University Hospital at 16 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in the absolute serum potassium level from baseline to 60 minutes (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04012138, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.