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

NCT05173584 | Unknown Phase 4

• 1 other identifier: 15993
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hyperkalemia; Albuterol; Levalbuterol; Heart rate

Outcome Measures

Primary Outcomes (2)

• Heart rate changes

  Heart rate changes over time measured as beats per minute

  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

  Serum potassium levels are measured at baseline and 90 minutes after treatment administration

Secondary Outcomes (4)

• ECG changes

  ECG changes detected at baseline and at 90 minutes after therapy

• Blood Pressure (BP) changes

  BP changes measured at baseline and at 30, 60, and 90 minutes after therapy

• Frequency of reported symptoms at presentation

  Symptoms reported only at the presentation of the patient

• Frequency of Adverse effects

  Adverse effects after treatment detected during the first two hours following treatment

Study Arms (2)

Levalbuterol Arm

EXPERIMENTAL

Drug: Levalbuterol

Albuterol Arm

ACTIVE COMPARATOR

Drug: Albuterol

Interventions

Levalbuterol DRUG

Levalbuterol nebulizer solution 1.25mg/3ml with a total dose of 5 mg (12ml) for each patient.

Levalbuterol Arm

Albuterol DRUG

Albuterol nebulizer solution 2.5 mg/3ml with a total dose of 0 mg (12ml) for each patient.

Also known as: salbutamol, racemic albuterol

Albuterol Arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients
• serum potassium level \>5.9 mEq/L

You may not qualify if:

• Pseudohyperkalemia:
• 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)

Sponsors & Collaborators

• University of Aleppo: lead

Study Sites (1)

Aleppo University Hospital

Aleppo, Aleppo Provice, 22743, Syria

RECRUITING

Related Publications (1)

• 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.

  PMID: 41437987 DERIVED

MeSH Terms

Conditions

Hyperkalemia

Interventions

Levalbuterol; Albuterol

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Mahmoud Malhis, MRCP

  Professor of Cardiology, Head of Cardiology division, Aleppo University Hospital, Faculty of Medicine, University of Aleppo.

  STUDY DIRECTOR

• Baraa Shebli, M.D.

  Cardiology Resident, Aleppo University Hospital, Faculty of Medicine, University of Aleppo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baraa Shebli, M.D.

CONTACT

+963949938945; bshebli@gmail.com

Mike Ghabally, M.D.

CONTACT

+963993856840; mike.ghabally@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Resident

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 30, 2021
• Study Start: November 4, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 30, 2021

Record last verified: 2021-12

Locations

SY (1)