Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Cardioversion (time and percentage)
研究概览
简要总结
Atrial fibrillation is a condition in which the heart's upper chambers, the atria, contract at an abnormally rapid rate. It is a common type of arrhythmia, and occurs in 1-2% of the general population. The prevalence of atrial fibrillation increases with age. Between 50 and 70% of patients with atrial fibrillation lasting <48 hours spontaneously convert to normal sinus rhythm, and drug therapy increases the likelihood of conversion to sinus rhythm. Another treatment option for conversion of atrial fibrillation and atrial flutter is electrical conversion. This is an effective treatment but requires anesthesia.
Current treatment strategy for medical conversion of atrial fibrillation and atrial flutter is to employ drugs that affect ion channel activity in atrial cardiomyocytes. However, such converting drugs all have potentially serious side effects and are expensive. Potassium, sodium, calcium, and magnesium molecules are the most important ions causing electric current in the heart tissue. Our hypothesis is that hypokalemia promotes atrial fibrillation/atrial flutter by a direct effect on cardiomyocytes. Accordingly, we also hypothesize that potassium infusion may convert atrial fibrillation/atrial flutter to normal sinus rhythm. If so, this would be an inexpensive treatment with potentially very few side effects.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with paroxysmal atrial fibrillation/atrial flutter with duration <48 hours
- •Plasma potassium ≤4,0 mmol/L.
- •Age ≥ 18 år
排除标准
- •Plasma potassium > 4,0 mmol/L
- •eGFR <30 mL/min
- •Patients on antiarrhythmic therapy (flecainid, amiodarone, dronedarone or sotalol)
- •Pregnancy
- •Breast feeding
- •Patients participating in a clinical trial during the last six months
- •Addison disease, adynamia episodic hereditary, or Sickle cell anemia
- •Metabolic acidosis, pH < 7,2
研究组 & 干预措施
Potassium
Potassium chloride infusion at a rate of 15 mmol/h (60 mmol KCl in 1000 ml of 5% glucose with a concentration of 0.05 mmol/mL, flow rate 265 mL/h). If the serum Mg ≤0.8 mmol/L, MgSO4 infusion (0.5 mmol/kg/24 hours in 1000 mL NaCl 0.9% corresponding to an infusion rate of approximately 42 mL/hour) will also be administered.
干预措施: Potassium chloride (Drug)
Placebo
5% glucose (flow rate 265 ml/h) as placebo infusion.
干预措施: Glucose 50 MG/ML (Drug)
结局指标
主要结局
Cardioversion (time and percentage)
时间窗: 24 hours
次要结局
- Atrial fibrillation at 3 months follow up visit and during 72 hours ECG-monitoring period.(At about 3 months follow up, plus additional 3 days ECG-monitoring)
研究者
Kiarash Tazmini
Kiarash Tazmini, MD
Diakonhjemmet Hospital