HyperkalemiaPhase 4NCT05173584
Levalbuterol Compared to Albuterol Regarding Cardiac Side Effects and Potassium Lowering Effects.
A Phase 4 study testing Levalbuterol and Albuterol in people with Hyperkalemia, run by University of Aleppo at 1 site in Syria.
Trial summary
Hyperkalemia is a common life-threatening electrolyte disturbance which may impair cardiac and many other organs' functions. Unfortunately, a well-established guideline for the treatment of hyperkalemia in the emergency setting is still missing. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- Levalbuterol and Albuterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- 4 Nov 2021to 31 Dec 2021
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adult patients
- serum potassium level >5.9 mEq/L
Who cannot join
- Pseudohyperkalemia:
- Hemolysis of blood sample
- Thrombocytosis > 10*6 /mm3
- Hyperleukocytosis > 10*5/mm3
- Mechanical Trauma during Venipuncture
- Fist clenching during blood drawing
Show all 24Show fewer
- Tourniquet time > 1 minute
- Diabetes acute complications
- DKA
- Hyperosmolar Hyperglycemic Syndrome
- Insulin-dependent diabetes mellitus ( if insulin is taken recently)
- Pregnant women
- Hyperthyroidism
- Hemodynamic instability
- Pacemakers if providing impulses (demand pacemakers that are not firing right now are included)
- Atrial fibrillation or any other arrhythmia
- Baseline tachycardia >120 bpm
- Acute exacerbations of HF
- Patients expected to require emergency intubation and ventilation
- Patients expected to require dialysis within the first 60 minutes
- Patients with hypersensitivity to the medication
- Patients with Acute Coronary Syndrome
- Patients on beta-blockers / beta-agonists or anti-arrhythmic drugs
- Patients with severe dyspnea or hypoxia SpO2 <90%
Trial locations and contacts
1 site in 1 country.
Syria1 site, 1 recruiting
- Recruiting
Aleppo University Hospital
Aleppo, Aleppo Provice, 22743
Rima Alassaf, admin@auh.edu.sy
Mike Ghabally, M.D.
About this study
Official title: Is Levalbuterol an Effective Treatment With Less Cardiac Side Effects Than Albuterol in Hyperkalemia Patients: A Randomized-controlled Clinical Trial Protocol.
Hyperkalemia is a common life-threatening electrolyte disturbance which may impair cardiac and many other organs' functions. Unfortunately, a well-established guideline for the treatment of hyperkalemia in the emergency setting is still missing. However, the last "Kidney Disease: Improving Global Outcomes (KDIGO)" conference proposed a treatment protocol for hyperkalemia and addressed controversies in this matter. Beta2-agonists were one of the main lines in the approach towards managing a patient with hyperkalemia. However, this evidence was only available for racemic albuterol.
Levalbuterol is the isolated R-enantiomer of racemic albuterol which is comprised of S- and R-enantiomers. Several lab and clinical studies have assessed the effect, affinity, and selectivity of each of the enantiomers. Few studies in medical literature have compared the difference between these two drugs regarding cardiac effects with inconclusive results, and even fewer studies have compared the efficacies of these two drugs regarding potassium lowering effect.
To the investigators' knowledge, no study to date has compared the efficacy and safety of albuterol compared to levalbuterol in hyperkalemic patients with the properly adjusted dosing. So, in clinical practice, the investigators wanted to know based on evidence if levalbuterol can be an effective substitute for albuterol in lowering potassium levels in hyperkalemia patients while yielding fewer cardiac side effects. To answer this question, the investigators designed a single-centered controlled clinical trial that includes adult hyperkalemia patients in Aleppo University Hospital.
- Conditions
- Hyperkalemia
- Being tested
- Levalbuterol, Albuterol
- Keywords
- Hyperkalemia, Albuterol, Levalbuterol, Heart rate
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevalbuterolDrug
Levalbuterol nebulizer solution 1.25mg/3ml with a total dose of 5 mg (12ml) for each patient.
AlbuterolDrug
Also called salbutamol, racemic albuterol
Albuterol nebulizer solution 2.5 mg/3ml with a total dose of 0 mg (12ml) for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Levalbuterol Arm | Experimental | Not described Receives: Drug: Levalbuterol |
| Albuterol Arm | Active comparator | Not described Receives: Drug: Albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate changes
Heart rate changes over time measured as beats per minute
Measured: Heart rate is measured at baseline before drug administration and at 15, 30, 45, 60, 90, 120 minutes after treatment.
Serum potassium level changes
Serum potassium level changes after treatment measured as mEq/L
Measured: Serum potassium levels are measured at baseline and 90 minutes after treatment administration
Secondary outcomes (4)
ECG changes
ECG Changes at presentation with hyperkalemia (Depressed ST segment, Diphasic T wave, Prominent U wave, Peaked T wave, Wide PR interval, Wide QRS duration, Peaked T wave, Loss of P wave, Sinusoidal wave, Others) and after treatment
Measured: ECG changes detected at baseline and at 90 minutes after therapy
Blood Pressure (BP) changes
BP changes over time measured as mmHg
Measured: BP changes measured at baseline and at 30, 60, and 90 minutes after therapy
Frequency of reported symptoms at presentation
Symptoms at presentation (Muscle weakness, Paresthesia, Paralysis, flushing, Nausea/Vomiting, Chest pain, Dyspnea, Fasciculation, Palpitations, Others).
Measured: Symptoms reported only at the presentation of the patient
Frequency of Adverse effects
Adverse effects following treatment (Fever, Palpitations, Hypoglycemia, Hypokalemia, Headache, Tremor, Nervousness, Nausea/vomiting, Lightheadedness)
Measured: Adverse effects after treatment detected during the first two hours following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start4 Nov 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aleppo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baraa Shebli, University of Aleppo
- Investigators
- Mahmoud Malhis, MRCP, Study director, Professor of Cardiology, Head of Cardiology division, Aleppo University Hospital, Faculty of Medicine, University of Aleppo.Baraa Shebli, M.D., Principal investigator, Cardiology Resident, Aleppo University Hospital, Faculty of Medicine, University of Aleppo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173584
- Sponsor's protocol ID
- 15993
- Status last verified
- Dec 2021
- First submitted
- 24 Nov 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shebli B, Ghabally M, Shabouk MB, Arnaout AY, Zeina MB, Malhis M. Assessing the cardiovascular and potassium lowering effects of levalbuterol compared to albuterol: a randomized control trial. Front Cardiovasc Med. 2025 Dec 8;12:1463999. doi: 10.3389/fcvm.2025.1463999. eCollection 2025.
PubMed 41437987
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Levalbuterol an Effective Treatment With Less Cardiac Side Effects Than Albuterol in Hyperkalemia Patients: A Randomized-controlled Clinical Trial Protocol.
- ClinicalTrials.gov ID
- NCT05173584
- Acronym / sponsor ID
- 15993
- Conditions
- Hyperkalemia
- Keywords
- Hyperkalemia, Albuterol, Levalbuterol, Heart rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AleppoUniversity, hospital or other
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Dec 2021 (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 life-threatening electrolyte disturbance which may impair cardiac and many other organs' functions. Unfortunately, a well-established guideline for the treatment of hyperkalemia in the emergency setting is still missing. However, the last "Kidney Disease: Improving Global Outcomes (KDIGO)" conference proposed a treatment protocol for hyperkalemia and addressed controversies in this matter. Beta2-agonists were one of the main lines in the approach towards managing a patient with hyperkalemia. However, this evidence was only available for racemic albuterol.
Levalbuterol is the isolated R-enantiomer of racemic albuterol which is comprised of S- and R-enantiomers. Several lab and clinical studies have assessed the effect, affinity, and selectivity of each of the enantiomers. Few studies in medical literature have compared the difference between these two drugs regarding cardiac effects with inconclusive results, and even fewer studies have compared the efficacies of these two drugs regarding potassium lowering effect.
To the investigators' knowledge, no study to date has compared the efficacy and safety of albuterol compared to levalbuterol in hyperkalemic patients with the properly adjusted dosing. So, in clinical practice, the investigators wanted to know based on evidence if levalbuterol can be an effective substitute for albuterol in lowering potassium levels in hyperkalemia patients while yielding fewer cardiac side effects. To answer this question, the investigators designed a single-centered controlled clinical trial that includes adult hyperkalemia patients in Aleppo University Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levalbuterol Arm | Experimental | Drug: Levalbuterol |
| Albuterol Arm | Active comparator | Drug: Albuterol |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients
- serum potassium level >5.9 mEq/L
Key exclusion criteria (24 listed)
- Pseudohyperkalemia:
- Diabetes acute complications
- Insulin-dependent diabetes mellitus ( if insulin is taken recently)
- Pregnant women
- Hyperthyroidism
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 |
|---|---|---|
| LevalbuterolLevalbuterol nebulizer solution 1.25mg/3ml with a total dose of 5 mg (12ml) for each patient. | Drug | Levalbuterol Arm |
| AlbuterolAlso: salbutamol, racemic albuterolAlbuterol nebulizer solution 2.5 mg/3ml with a total dose of 0 mg (12ml) for each patient. | Drug | Albuterol Arm |
Primary outcome
Heart rate changes
Time frame: Heart rate is measured at baseline before drug administration and at 15, 30, 45, 60, 90, 120 minutes after treatment.
Heart rate changes over time measured as beats per minute
Serum potassium level changes
Time frame: Serum potassium levels are measured at baseline and 90 minutes after treatment administration
Serum potassium level changes after treatment measured as mEq/L
4 secondary outcomes
ECG changes
Time frame: ECG changes detected at baseline and at 90 minutes after therapy
Blood Pressure (BP) changes
Time frame: BP changes measured at baseline and at 30, 60, and 90 minutes after therapy
Frequency of reported symptoms at presentation
Time frame: Symptoms reported only at the presentation of the patient
Frequency of Adverse effects
Time frame: Adverse effects after treatment detected during the first two hours following treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Derived from this study: PubMed 41437987Shebli B, Ghabally M, Shabouk MB, Arnaout AY, Zeina MB, Malhis M. Assessing the cardiovascular and potassium lowering effects of levalbuterol compared to albuterol: a randomized control trial. Front Cardiovasc Med. 2025 Dec 8;12:1463999. doi: 10.3389/fcvm.2025.1463999. eCollection 2025.
Related trials for Hyperkalemia
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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
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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.
Mahmoud Malhis, MRCP study director
Professor of Cardiology, Head of Cardiology division, Aleppo University Hospital, Faculty of Medicine, University of Aleppo.
Baraa Shebli, M.D. principal investigator
Cardiology Resident, Aleppo University Hospital, Faculty of Medicine, University of Aleppo
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 Levalbuterol and Albuterol in people with Hyperkalemia, run by University of Aleppo at 1 site in Syria.
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 2 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 30 Dec 2021. 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 Syria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baraa Shebli, M.D. (+963949938945, bshebli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate changes (time frame: Heart rate is measured at baseline before drug administration and at 15, 30, 45, 60, 90, 120 minutes after treatment.). The study lists 2 primary outcomes in all. 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 NCT05173584, 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 30 Dec 2021; AzTrials last refreshed its copy on 6 Nov 2026.