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

Hyperkalemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05173584
• Other study ID #: 15993
• Status: Recruiting
• Phase: Phase 4
• Start date: November 4, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2021
• Source: University of Aleppo
• Contact: Baraa Shebli, M.D.
• Phone: +963949938945
• Email: bshebli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Hyperkalemia

Intervention

Drug:
• Levalbuterol
Levalbuterol nebulizer solution 1.25mg/3ml with a total dose of 5 mg (12ml) for each patient.
• Albuterol
Albuterol nebulizer solution 2.5 mg/3ml with a total dose of 0 mg (12ml) for each patient.

Locations

Country	Name	City	State
Syrian Arab Republic	Aleppo University Hospital	Aleppo	Aleppo Provice

Sponsors (1)

Lead Sponsor	Collaborator
University of Aleppo

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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	ECG changes detected at baseline and at 90 minutes after therapy
Secondary	Blood Pressure (BP) changes	BP changes over time measured as mmHg	BP changes measured at baseline and at 30, 60, and 90 minutes after therapy
Secondary	Frequency of reported symptoms at presentation	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
Secondary	Frequency of Adverse effects	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