NCT05173584

Levalbuterol Compared to Albuterol Regarding Cardiac Side Effects and Potassium Lowering Effects.

Is Levalbuterol an Effective Treatment With Less Cardiac Side Effects Than Albuterol in Hyperkalemia Patients: A Randomized-controlled Clinical Trial Protocol.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Aleppo · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
DRUG	Levalbuterol	Levalbuterol nebulizer solution 1.25mg/3ml with a total dose of 5 mg (12ml) for each patient.
DRUG	Albuterol	Albuterol nebulizer solution 2.5 mg/3ml with a total dose of 0 mg (12ml) for each patient.

Timeline

• Start date: 2021-11-04
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-12-30
• Last updated: 2021-12-30

Locations

1 site across 1 country: Syria