Levalbuterol Compared to Albuterol Regarding Cardiac Side Effects and Potassium Lowering Effects.
NCT ID: NCT05173584
Last Updated: 2021-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2021-11-04
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Genetic Determinants of the Hypokalemic and Hyperglycemic Effect of Albuterol Inhalation
NCT00162487
Assessment of Hyperkalemia's Illness and Treatment Burden in Chronic Kidney Disease and Heart Failure Patients: HK Registry Pilot Study
NCT04466969
Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy
NCT01893788
Hyperkalaemia and Its Impact on Therapy with RAASi
NCT04249648
The Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients
NCT06736184
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Levalbuterol Arm
Levalbuterol
Levalbuterol nebulizer solution 1.25mg/3ml with a total dose of 5 mg (12ml) for each patient.
Albuterol Arm
Albuterol
Albuterol nebulizer solution 2.5 mg/3ml with a total dose of 0 mg (12ml) for each patient.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Levalbuterol
Levalbuterol nebulizer solution 1.25mg/3ml with a total dose of 5 mg (12ml) for each patient.
Albuterol
Albuterol nebulizer solution 2.5 mg/3ml with a total dose of 0 mg (12ml) for each patient.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* serum potassium level \>5.9 mEq/L
Exclusion Criteria
* Hemolysis of blood sample
* Thrombocytosis \> 10\*6 /mm3
* Hyperleukocytosis \> 10\*5/mm3
* Mechanical Trauma during Venipuncture
* Fist clenching during blood drawing
* 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%
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Aleppo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Baraa Shebli
Cardiology Resident
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mahmoud Malhis, MRCP
Role: STUDY_DIRECTOR
Professor of Cardiology, Head of Cardiology division, Aleppo University Hospital, Faculty of Medicine, University of Aleppo.
Baraa Shebli, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cardiology Resident, Aleppo University Hospital, Faculty of Medicine, University of Aleppo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aleppo University Hospital
Aleppo, Aleppo Provice, Syria
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
15993
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.