HyperkalemiaPhase 4NCT06036823
5 Versus 10 Units of Insulin in Hyperkalemia Management
A Phase 4 study testing Insulin regular, Dextrose 50 and salbutamol in people with Hyperkalemia and Potassium Imbalance, run by Oman Medical Speciality Board at 1 site in Oman.
Trial summary
The goal of this study is to compare 5 units of intravenous Regular insulin to 10 units of intravenous regular insulin in the management of hyperkalemia. We will measure the efficacy of these 2 doses of insulin in reducing hyperkalemia at 2 hours from administration using the main laboratory serum values. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemia, Potassium Imbalance, Electrolyte Imbalance
- What is being tested?
- Insulin regular, Dextrose 50 and salbutamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteOman
- Study dates
- 1 Oct 2023to 30 Sep 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
- Hyperkalemia patients with lab potassium levels equal to or more than 5.5 mEq/L (≥ 5.5 mEq/L)+.
- Adult: age 18 years or more.
- Agreed to participate in the study.
- If an investigator decides to start anti-hyperkalemia medications based on the VBG/ABG patient can be enrolled but if the main laboratory value is less than 5.5 mEq/L patients will be excluded
Who cannot join
- Cardiac arrest
- Hyperglycemia with random blood sugar 20 mmol/L (13) or with acute diabetic complications like Diabetic Ketoacidosis / Hyperosmolar Hyperglycemic State.
- Hypoglycemia with random blood sugar (RBS) ≤ 3.89 mmol/l in Diabetic patients and less than 3 mmol/l in non-diabetic patients.
- Allergies for any medication in the protocol.
- Pregnancy.
- Hemolyzed potassium level as reported by the main lab.
Show all 10Show fewer
- Hemolysis, Tumor lysis syndrome, or Rhabdomyolysis due to the ongoing release of potassium.
- Acidosis with a pH less than 7.1 will require Sodium bicarbonate (NaHO3).
- A patient who will need urgent Furosemide (Lasix), and or dialysis during the study period of 2 hours.
- Refused to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 5 Versus 10 Units of Insulin in Hyperkalemia Management: Multi-center, Prospective, Double-blind, Non-inferiority, Randomized Control Trial.
The goal of this study is to compare 5 units of intravenous Regular insulin to 10 units of intravenous regular insulin in the management of hyperkalemia. We will measure the efficacy of these 2 doses of insulin in reducing hyperkalemia at 2 hours from administration using the main laboratory serum values.
Read the detailed description
Introduction: Hyperkalaemia is a serum Potassium (K) level of more than 5.5 mEq/L. It is a common emergency medicine presentation and can be life-threatening. Because of the emergency in correcting hyperkalemia, different medications are used to reduce high potassium levels to normal as soon as possible. Salbutamol inhalers, Glucose solutions, and Insulin are the main medications for managing hyperkalemia. Insulin and Dextrose shift potassium ions into body cells by stimulating the sodium/potassium ATP pump. Its effect starts in less than fifteen minutes and can last up to sixty minutes. It usually reduces potassium up to 1.1 mEq/l. There are different recommendations for Insulin dose and rate of administration for patients with hyperkalemia.
Method: This will be a multi-center, prospective, double-blind, non-inferiority, randomized control trial. 336 hyperkalemia patients will be randomized to the intervention group 5 units of intravenous Regular insulin and 10 units of intravenous insulin groups with fifty ml of Dextrose Fifty percent. They will be enrolled once their potassium level is 5.5mEq/L or more. The attending physician and patient will be blinded about the dose of insulin that the patient received. Serum potassium will be measured at 0 and at 120 minutes from the start of the medications. Random blood glucose will be measured at 0, 60, and 120 minutes by Glucometer. The safety of our patients will be assessed by documentation of all adverse events, vital signs, and clinical assessment before and after drug administration. The study will end at 2 hours from insulin administration.
Aim: Our research idea aims to compare two recommended doses of Insulin (5 Units vs. 10 Units of Regular insulin given intravenously over thirty minutes) in the management of patients with hyperkalemia.
Primary objective: Mean reduction in serum potassium level using the main laboratory results at two hours from medication administration.
Secondary objectives: effect of initial (baseline) potassium level on the mean potassium reduction, and frequency of hypoglycemia between the 2 groups. Does the initial (baseline) blood glucose level will affect the function of insulin/dextrose in lowering potassium levels?
Patient Population: Adult patients (Aged 18 years and older) who present to the Emergency department at Sultan Qaboos University, Royal Hospital and Sohar hospital for evaluation and are found to have potassium levels of 5.5 mEq/L and above.
Intervention: Single dose of 5 units of intravenous insulin over 30 minutes with 50 ml of Dextrose 50%.
Clinical Measurement: Mean reduction of potassium level using the main laboratory results at 2 hours from insulin/dextrose administration. Hypoglycemia will be followed by a bedside glucometer.
Outcome: reduction of potassium level at 2 hours from medication administration and medication safety.
- Being tested
- Insulin regular, Dextrose 50, salbutamol
- Keywords
- insulin, hyperkalemia, hypoglycmiea, anti-hyperkalemia, electrolytes abnormalities
- 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.
Insulin regularDrug
Intravenous insulin
Dextrose 50Drug
to be given to both arms
salbutamolDrug
to be given to all patients
| Study group | Role | What they receive |
|---|---|---|
| 5 units of intravenous R insulin | Active comparator | Will receive:
IV Insulin Regular 5 units with Dextrose 50 % 50 ml over 30 minutes. Salbutamol 10 mg Nebulization over 15 minutes. Receives: Drug: Insulin regular; Drug: Dextrose 50; Drug: salbutamol |
| 10 units of intravenous R insulin | Active comparator | Will Receive:
IV Insulin Regular 10 units with Dextrose 50 % 50 ml over 30 minutes. Salbutamol 10 mg nebulization over 15 minutes. Receives: Drug: Insulin regular; Drug: Dextrose 50; Drug: salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the efficacy of two intravenous insulin doses (5 units and 10 units) in reducing serum potassium level in patients receiving hyperkalemia treatment using the main laboratory measurements. (the aim of reduction of 0.6 mmol/l +/- 0.2 mmol/L) (1).
Once the baseline potassium identified 5.5 mmol/L or more patient will be enrolled after taken an informed consent. Blood sample will be collected and send to the main laboratory for analysis at two hours from medications administration. The efficacy of the 2 doses of insulin in reducing potassium level will be measured at 2 hours from administration of medications by comparing the amount of changes of potassium level at two hours from baseline level.
- The main laboratory result will be used to measure and follow the patients. results will be reported in mmol/L.
Measured: At 2 hours from administration of medications
Secondary outcomes (3)
Study the mean difference of the response to the anti-hyperkalemic measures based on the level of initial potassium (serum potassium before given any medications - At baseline).
(The investigators will categorize potassium levels into groups mild (5.5-6 mmol/l), moderate (6-6.5 mmol/l), and severe (>6.5 mmol/l) and will see the mean difference in reduction in potassium level between the 2 doses).
Measured: 2 hours from administration of medications
Association of mean potassium reduction with initial blood sugar level on potassium reduction
The investigators will categorize blood sugar into groups: Below 10mmol/L, 10.1-14.9 mmol/L, and 15 - 19.9mmol/L among each group the investigators will see the mean potassium reduction levels.
Measured: 2 hours from administration of medications
Incidence of hypoglycemia (random blood sugar (RBS) ≤ 3.89 mmol/l in Diabetic patients and less than 3 mmol/l in non-diabetic patients) (12) and risk factor Characteristics of patients with a higher risk of developing hypoglycemia
The investigators will investigate which group of patients will have a high risk of hypoglycemia ((e.g.: initial Glucose level, initial creatinin/renal function, comorbidities, type of dialysis….
Measured: 2 hours from administration of medications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Oct 2023
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- 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
- Factorial
- Model description
- the study group will receive 5 units of intravenous insulin control group will receive 10 unites of IV insulin
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oman Medical Speciality Board
- Sponsor type
- Other government
- Collaborators
- Sultan Qaboos University
- Responsible party
- Principal investigator, Adnan Al-Ajmi, Oman Medical Speciality Board
- Investigators
- Suad Al-Abri, Principal investigator, Sultan Qaboos University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036823
- Sponsor's protocol ID
- MREC #2779
- Status last verified
- Dec 2025
- First submitted
- 10 Aug 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Verdier M, DeMott JM, Peksa GD. A comparison of insulin doses for treatment of hyperkalaemia in intensive care unit patients with renal insufficiency. Aust Crit Care. 2022 May;35(3):258-263. doi: 10.1016/j.aucc.2021.05.004. Epub 2021 Jun 21.
PubMed 34167889Ron M. Walls, MD. Hyperkalemia. Rosen emergency medince Concepts and Clinical practice. 9th. Philadelphia : Elsevier, 2018, 117, pp. 1516 - 1519.
Judith E. Tintinalli, MD, MS. Hyperkalemia. Tintinalli's Emergency Medicine a comprehensive study guide. 9th. s.l. : McGraw-Hill Education, 2020, 17, p. 89.
McNicholas BA, Pham MH, Carli K, Chen CH, Colobong-Smith N, Anderson AE, Pham H. Treatment of Hyperkalemia With a Low-Dose Insulin Protocol Is Effective and Results in Reduced Hypoglycemia. Kidney Int Rep. 2017 Oct 24;3(2):328-336. doi: 10.1016/j.ekir.2017.10.009. eCollection 2018 Mar.
PubMed 29725636Moussavi K, Nguyen LT, Hua H, Fitter S. Comparison of IV Insulin Dosing Strategies for Hyperkalemia in the Emergency Department. Crit Care Explor. 2020 Apr 29;2(4):e0092. doi: 10.1097/CCE.0000000000000092. eCollection 2020 Apr.
PubMed 32426734LaRue HA, Peksa GD, Shah SC. A Comparison of Insulin Doses for the Treatment of Hyperkalemia in Patients with Renal Insufficiency. Pharmacotherapy. 2017 Dec;37(12):1516-1522. doi: 10.1002/phar.2038. Epub 2017 Nov 27.
PubMed 28976587Moussavi K, Garcia J, Tellez-Corrales E, Fitter S. Reduced alternative insulin dosing in hyperkalemia: A meta-analysis of effects on hypoglycemia and potassium reduction. Pharmacotherapy. 2021 Jul;41(7):598-607. doi: 10.1002/phar.2596. Epub 2021 Jun 1.
PubMed 33993515Harel Z, Kamel KS. Optimal Dose and Method of Administration of Intravenous Insulin in the Management of Emergency Hyperkalemia: A Systematic Review. PLoS One. 2016 May 5;11(5):e0154963. doi: 10.1371/journal.pone.0154963. eCollection 2016.
PubMed 27148740Garcia J, Pintens M, Morris A, Takamoto P, Baumgartner L, Tasaka CL. Reduced Versus Conventional Dose Insulin for Hyperkalemia Treatment. J Pharm Pract. 2020 Jun;33(3):262-266. doi: 10.1177/0897190018799220. Epub 2018 Sep 6.
PubMed 30189765
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5 Versus 10 Units of Insulin in Hyperkalemia Management: Multi-center, Prospective, Double-blind, Non-inferiority, Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT06036823
- Acronym / sponsor ID
- MREC #2779
- Keywords
- insulin, hyperkalemia, hypoglycmiea, anti-hyperkalemia, electrolytes abnormalities
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Oman Medical Speciality BoardOther government
- Collaborators
- Sultan Qaboos University
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 14 Sep 2023 (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.
The goal of this study is to compare 5 units of intravenous Regular insulin to 10 units of intravenous regular insulin in the management of hyperkalemia. We will measure the efficacy of these 2 doses of insulin in reducing hyperkalemia at 2 hours from administration using the main laboratory serum values.
Detailed description
Introduction: Hyperkalaemia is a serum Potassium (K) level of more than 5.5 mEq/L. It is a common emergency medicine presentation and can be life-threatening. Because of the emergency in correcting hyperkalemia, different medications are used to reduce high potassium levels to normal as soon as possible. Salbutamol inhalers, Glucose solutions, and Insulin are the main medications for managing hyperkalemia. Insulin and Dextrose shift potassium ions into body cells by stimulating the sodium/potassium ATP pump. Its effect starts in less than fifteen minutes and can last up to sixty minutes. It usually reduces potassium up to 1.1 mEq/l. There are different recommendations for Insulin dose and rate of administration for patients with hyperkalemia.
Method: This will be a multi-center, prospective, double-blind, non-inferiority, randomized control trial. 336 hyperkalemia patients will be randomized to the intervention group 5 units of intravenous Regular insulin and 10 units of intravenous insulin groups with fifty ml of Dextrose Fifty percent. They will be enrolled once their potassium level is 5.5mEq/L or more. The attending physician and patient will be blinded about the dose of insulin that the patient received. Serum potassium will be measured at 0 and at 120 minutes from the start of the medications. Random blood glucose will be measured at 0, 60, and 120 minutes by Glucometer. The safety of our patients will be assessed by documentation of all adverse events, vital signs, and clinical assessment before and after drug administration. The study will end at 2 hours from insulin administration.
Aim: Our research idea aims to compare two recommended doses of Insulin (5 Units vs. 10 Units of Regular insulin given intravenously over thirty minutes) in the management of patients with hyperkalemia.
Primary objective: Mean reduction in serum potassium level using the main laboratory results at two hours from medication administration.
Secondary objectives: effect of initial (baseline) potassium level on the mean potassium reduction, and frequency of hypoglycemia between the 2 groups. Does the initial (baseline) blood glucose level will affect the function of insulin/dextrose in lowering potassium levels?
Patient Population: Adult patients (Aged 18 years and older) who present to the Emergency department at Sultan Qaboos University, Royal Hospital and Sohar hospital for evaluation and are found to have potassium levels of 5.5 mEq/L and above.
Intervention: Single dose of 5 units of intravenous insulin over 30 minutes with 50 ml of Dextrose 50%.
Clinical Measurement: Mean reduction of potassium level using the main laboratory results at 2 hours from insulin/dextrose administration. Hypoglycemia will be followed by a bedside glucometer.
Outcome: reduction of potassium level at 2 hours from medication administration and medication safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- the study group will receive 5 units of intravenous insulin control group will receive 10 unites of IV insulin
| Arm | Type | Receives |
|---|---|---|
| 5 units of intravenous R insulin | Active comparator | Drug: Insulin regular, Drug: Dextrose 50, Drug: salbutamolWill receive: IV Insulin Regular 5 units with Dextrose 50 % 50 ml over 30 minutes. Salbutamol 10 mg Nebulization over 15 minutes. |
| 10 units of intravenous R insulin | Active comparator | Drug: Insulin regular, Drug: Dextrose 50, Drug: salbutamolWill Receive: IV Insulin Regular 10 units with Dextrose 50 % 50 ml over 30 minutes. Salbutamol 10 mg nebulization over 15 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hyperkalemia patients with lab potassium levels equal to or more than 5.5 mEq/L (≥ 5.5 mEq/L)+.
- Adult: age 18 years or more.
- Agreed to participate in the study.
Key exclusion criteria (10 listed)
- Cardiac arrest
- Hyperglycemia with random blood sugar 20 mmol/L (13) or with acute diabetic complications like Diabetic Ketoacidosis / Hyperosmolar Hyperglycemic State.
- Hypoglycemia with random blood sugar (RBS) ≤ 3.89 mmol/l in Diabetic patients and less than 3 mmol/l in non-diabetic patients.
- Allergies for any medication in the protocol.
- Pregnancy.
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 |
|---|---|---|
| Insulin regularIntravenous insulin | Drug | 10 units of intravenous R insulin, 5 units of intravenous R insulin |
| Dextrose 50to be given to both arms | Drug | 10 units of intravenous R insulin, 5 units of intravenous R insulin |
| salbutamolto be given to all patients | Drug | 10 units of intravenous R insulin, 5 units of intravenous R insulin |
Primary outcome
To study the efficacy of two intravenous insulin doses (5 units and 10 units) in reducing serum potassium level in patients receiving hyperkalemia treatment using the main laboratory measurements. (the aim of reduction of 0.6 mmol/l +/- 0.2 mmol/L) (1).
Time frame: At 2 hours from administration of medications
Once the baseline potassium identified 5.5 mmol/L or more patient will be enrolled after taken an informed consent. Blood sample will be collected and send to the main laboratory for analysis at two hours from medications administration. The efficacy of the 2 doses of insulin in reducing potassium level will be measured at 2 hours from administration of medications by comparing the amount of changes of potassium level at two hours from baseline level. - The main laboratory result will be used to measure and follow the patients. results will be reported in mmol/L.
3 secondary outcomes
Study the mean difference of the response to the anti-hyperkalemic measures based on the level of initial potassium (serum potassium before given any medications - At baseline).
Time frame: 2 hours from administration of medications
Association of mean potassium reduction with initial blood sugar level on potassium reduction
Time frame: 2 hours from administration of medications
Incidence of hypoglycemia (random blood sugar (RBS) ≤ 3.89 mmol/l in Diabetic patients and less than 3 mmol/l in non-diabetic patients) (12) and risk factor Characteristics of patients with a higher risk of developing hypoglycemia
Time frame: 2 hours from administration of medications
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 22 Dec 2025.
- Background: PubMed 34167889Verdier M, DeMott JM, Peksa GD. A comparison of insulin doses for treatment of hyperkalaemia in intensive care unit patients with renal insufficiency. Aust Crit Care. 2022 May;35(3):258-263. doi: 10.1016/j.aucc.2021.05.004. Epub 2021 Jun 21.
- BackgroundRon M. Walls, MD. Hyperkalemia. Rosen emergency medince Concepts and Clinical practice. 9th. Philadelphia : Elsevier, 2018, 117, pp. 1516 - 1519.
- BackgroundJudith E. Tintinalli, MD, MS. Hyperkalemia. Tintinalli's Emergency Medicine a comprehensive study guide. 9th. s.l. : McGraw-Hill Education, 2020, 17, p. 89.
- Background: PubMed 29725636McNicholas BA, Pham MH, Carli K, Chen CH, Colobong-Smith N, Anderson AE, Pham H. Treatment of Hyperkalemia With a Low-Dose Insulin Protocol Is Effective and Results in Reduced Hypoglycemia. Kidney Int Rep. 2017 Oct 24;3(2):328-336. doi: 10.1016/j.ekir.2017.10.009. eCollection 2018 Mar.
- Background: PubMed 32426734Moussavi K, Nguyen LT, Hua H, Fitter S. Comparison of IV Insulin Dosing Strategies for Hyperkalemia in the Emergency Department. Crit Care Explor. 2020 Apr 29;2(4):e0092. doi: 10.1097/CCE.0000000000000092. eCollection 2020 Apr.
- Background: PubMed 28976587LaRue HA, Peksa GD, Shah SC. A Comparison of Insulin Doses for the Treatment of Hyperkalemia in Patients with Renal Insufficiency. Pharmacotherapy. 2017 Dec;37(12):1516-1522. doi: 10.1002/phar.2038. Epub 2017 Nov 27.
- Background: PubMed 33993515Moussavi K, Garcia J, Tellez-Corrales E, Fitter S. Reduced alternative insulin dosing in hyperkalemia: A meta-analysis of effects on hypoglycemia and potassium reduction. Pharmacotherapy. 2021 Jul;41(7):598-607. doi: 10.1002/phar.2596. Epub 2021 Jun 1.
- Background: PubMed 27148740Harel Z, Kamel KS. Optimal Dose and Method of Administration of Intravenous Insulin in the Management of Emergency Hyperkalemia: A Systematic Review. PLoS One. 2016 May 5;11(5):e0154963. doi: 10.1371/journal.pone.0154963. eCollection 2016.
- Background: PubMed 30189765Garcia J, Pintens M, Morris A, Takamoto P, Baumgartner L, Tasaka CL. Reduced Versus Conventional Dose Insulin for Hyperkalemia Treatment. J Pharm Pract. 2020 Jun;33(3):262-266. doi: 10.1177/0897190018799220. Epub 2018 Sep 6.
- David B Mount, MD. Causes and evaluation of hyperkalemia in adultsLink provided by the sponsor.
- Treatment and prevention of hyperkalemia in adultsLink provided by the sponsor.
- Hyperkalemia Treatment \& ManagementLink provided by the sponsor.
- Hypoglycemia in adults without diabetes mellitus: Clinical manifestations, diagnosis, and causesLink provided by the sponsor.
- Hyper K recognition and treatment of Hyperkalemia in the ED. American College of Emergency Physicians.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Suad Al-Abri principal investigator
Sultan Qaboos University hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin regular, Dextrose 50 and salbutamol in people with Hyperkalemia and Potassium Imbalance, run by Oman Medical Speciality Board at 1 site in Oman.
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 10 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Oman. 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?
To study the efficacy of two intravenous insulin doses (5 units and 10 units) in reducing serum potassium level in patients receiving hyperkalemia treatment using the main laboratory measurements. (the aim of reduction of 0.6 mmol/l +/- 0.2 mmol/L) (1). (time frame: At 2 hours from administration of medications). 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 NCT06036823, which also lists 9 linked publications.
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 22 Dec 2025.