A Phase 4 interventional study of Levalbuterol and Albuterol in Hyperkalemia, sponsored by University of Aleppo. Status unknown at 1 site in Syrian Arab Republic. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2021-12-30.
Sponsored by University of Aleppo · Phase 4, Interventional, and Treatment
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.
122 studies on the registry are indexed under Hyperkalemia; 24 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 92 interventional studies indexed under Hyperkalemia.
Browse Hyperkalemia studies →University of Aleppo is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pseudohyperkalemia:
Diabetes acute complications
Drug: Levalbuterol
Drug: Albuterol
Levalbuterol nebulizer solution 1.25mg/3ml with a total dose of 5 mg (12ml) for each patient.
Albuterol nebulizer solution 2.5 mg/3ml with a total dose of 0 mg (12ml) for each patient.
Also known as: salbutamol, racemic albuterol
Heart rate changes
Heart rate changes over time measured as beats per minute
Time frame: 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
Time frame: Serum potassium levels are measured at baseline and 90 minutes after treatment administration
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
Time frame: ECG changes detected at baseline and at 90 minutes after therapy
Blood Pressure (BP) changes
BP changes over time measured as mmHg
Time frame: 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).
Time frame: 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)
Time frame: Adverse effects after treatment detected during the first two hours following treatment
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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University of Aleppo