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

December 12, 2021 updated by: Baraa Shebli, University of Aleppo

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Syrian Arab Republic
    • Aleppo Provice
      • Aleppo, Aleppo Provice, Syrian Arab Republic, 22743
        • Recruiting
        • Aleppo University Hospital
        • Contact:
        • Sub-Investigator:
          • Mike Ghabally, M.D.
        • Sub-Investigator:
          • Hamed Kozom, M.D.
        • Sub-Investigator:
          • Muhammad Besher Shabouk, Undergraduate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
  • 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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Levalbuterol Arm
Drug: Levalbuterol
Levalbuterol nebulizer solution 1.25mg/3ml with a total dose of 5 mg (12ml) for each patient.
ACTIVE_COMPARATOR: Albuterol Arm
Drug: Albuterol
Albuterol nebulizer solution 2.5 mg/3ml with a total dose of 0 mg (12ml) for each patient.
Other Names:
  • salbutamol, racemic albuterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate changes
Time Frame: Heart rate is measured at baseline before drug administration and at 15, 30, 45, 60, 90, 120 minutes after treatment.
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
Time Frame: Serum potassium levels are measured at baseline and 90 minutes after treatment administration
Serum potassium level changes after treatment measured as mEq/L
Serum potassium levels are measured at baseline and 90 minutes after treatment administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ECG changes
Time Frame: ECG changes detected at baseline and at 90 minutes after therapy
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
ECG changes detected at baseline and at 90 minutes after therapy
Blood Pressure (BP) changes
Time Frame: BP changes measured at baseline and at 30, 60, and 90 minutes after therapy
BP changes over time measured as mmHg
BP changes measured at baseline and at 30, 60, and 90 minutes after therapy
Frequency of reported symptoms at presentation
Time Frame: Symptoms reported only at the presentation of the patient
Symptoms at presentation (Muscle weakness, Paresthesia, Paralysis, flushing, Nausea/Vomiting, Chest pain, Dyspnea, Fasciculation, Palpitations, Others).
Symptoms reported only at the presentation of the patient
Frequency of Adverse effects
Time Frame: Adverse effects after treatment detected during the first two hours following treatment
Adverse effects following treatment (Fever, Palpitations, Hypoglycemia, Hypokalemia, Headache, Tremor, Nervousness, Nausea/vomiting, Lightheadedness)
Adverse effects after treatment detected during the first two hours following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aleppo

Investigators

  • Study Director: Mahmoud Malhis, MRCP, Professor of Cardiology, Head of Cardiology division, Aleppo University Hospital, Faculty of Medicine, University of Aleppo.
  • Principal Investigator: Baraa Shebli, M.D., Cardiology Resident, Aleppo University Hospital, Faculty of Medicine, University of Aleppo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 4, 2021

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

December 12, 2021

First Posted (ACTUAL)

December 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 30, 2021

Last Update Submitted That Met QC Criteria

December 12, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15993

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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