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临床试验/NCT05173584
NCT05173584Unknown4 期

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

University of Aleppo1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年11月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
30
试验地点
1
主要终点
Heart rate changes

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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
  • 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%

研究组 & 干预措施

Levalbuterol Arm

Experimental

干预措施: Levalbuterol (Drug)

Albuterol Arm

Active Comparator

干预措施: Albuterol (Drug)

结局指标

主要结局

Heart rate changes

时间窗: 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

时间窗: Serum potassium levels are measured at baseline and 90 minutes after treatment administration

Serum potassium level changes after treatment measured as mEq/L

次要结局

  • Frequency of reported symptoms at presentation(Symptoms reported only at the presentation of the patient)
  • ECG changes(ECG changes detected at baseline and at 90 minutes after therapy)
  • Blood Pressure (BP) changes(BP changes measured at baseline and at 30, 60, and 90 minutes after therapy)
  • Frequency of Adverse effects(Adverse effects after treatment detected during the first two hours following treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Baraa Shebli

Cardiology Resident

University of Aleppo

研究点 (1)

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