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

Sponsor

University of Aleppo (Other)

Overall Status

Recruiting

CT.gov ID

NCT05173584

Collaborator

(none)

Enrollment

Location

Arms

1.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperkalemia	Drug: Levalbuterol Drug: Albuterol	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 4, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Heart rate changes [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
Serum potassium level changes [Serum potassium levels are measured at baseline and 90 minutes after treatment administration]
Serum potassium level changes after treatment measured as mEq/L

Secondary Outcome Measures

ECG changes [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
Blood Pressure (BP) changes [BP changes measured at baseline and at 30, 60, and 90 minutes after therapy]
BP changes over time measured as mmHg
Frequency of reported symptoms at presentation [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).
Frequency of Adverse effects [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aleppo University Hospital	Aleppo	Aleppo Provice	Syrian Arab Republic	22743

Sponsors and Collaborators

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