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
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2021-11-04
2021-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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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
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Eligibility Criteria
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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
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University of Aleppo
OTHER
Responsible Party
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Baraa Shebli
Cardiology Resident
Principal Investigators
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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
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Aleppo University Hospital
Aleppo, Aleppo Provice, Syria
Countries
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Central Contacts
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Facility Contacts
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Rima Alassaf
Role: primary
Other Identifiers
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15993
Identifier Type: -
Identifier Source: org_study_id