Clinical trial NCT05173584: Levalbuterol Compared to Albuterol Regarding Cardiac Side Effects and Potassium Lowering Effects.
Official title: Is Levalbuterol an Effective Treatment With Less Cardiac Side Effects Than Albuterol in Hyperkalemia Patients: A Randomized-controlled Clinical Trial Protocol.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hyperkalemia
Keywords: Hyperkalemia
Albuterol
Levalbuterol
Heart rate
Lead sponsor: University of Aleppo
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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%

Primary outcomes:
measure: Heart rate changes
timeFrame: Heart rate is measured at baseline before drug administration and at 15, 30, 45, 60, 90, 120 minutes after treatment.
measure: Serum potassium level changes
timeFrame: Serum potassium levels are measured at baseline and 90 minutes after treatment administration
Secondary outcomes:
measure: ECG changes
timeFrame: ECG changes detected at baseline and at 90 minutes after therapy
measure: Blood Pressure (BP) changes
timeFrame: BP changes measured at baseline and at 30, 60, and 90 minutes after therapy
measure: Frequency of reported symptoms at presentation
timeFrame: Symptoms reported only at the presentation of the patient
measure: Frequency of Adverse effects
timeFrame: Adverse effects after treatment detected during the first two hours following treatment
Other outcomes:
Locations:
city: Aleppo
country: Syrian Arab Republic
facility: Aleppo University Hospital
state: Aleppo Provice
Study officials:
affiliation: Professor of Cardiology, Head of Cardiology division, Aleppo University Hospital, Faculty of Medicine, University of Aleppo.
name: Mahmoud Malhis, MRCP
role: STUDY_DIRECTOR
affiliation: Cardiology Resident, Aleppo University Hospital, Faculty of Medicine, University of Aleppo
name: Baraa Shebli, M.D.
role: PRINCIPAL_INVESTIGATOR
References: