Levalbuterol Compared to Albuterol Regarding Cardiac Side Effects and Potassium Lowering Effects.
- Registration Number
- NCT05173584
- Lead Sponsor
- University of Aleppo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- adult patients
- serum potassium level >5.9 mEq/L
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Levalbuterol Arm Levalbuterol - Albuterol Arm Albuterol -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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).
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 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)
Trial Locations
- Locations (1)
Aleppo University Hospital
🇸🇾Aleppo, Aleppo Provice, Syrian Arab Republic