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临床试验/NCT01817439
NCT01817439Unknown3 期

The Effect of Intravenous vs. Oral Administration of Amiodarone on the Incidence Rate of Phlebitis Among Patients With Recent Onset of Atrial Fibrillation (AF)

Western Galilee Hospital-Nahariya1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
104
试验地点
1
主要终点
Incidence rate of phlebitis

研究概览

简要总结

Atrial fibrillation (AF) remains a significant contributor to cardiovascular morbidity. Amiodarone is a potent antiarrhythmic drug; however, patients receiving IV amiodarone are at high risk for phlebitis. Phlebitis may lead to infection, additional medical intervention, delay in treatment, and prolonged hospitalization. Therefore, examining new therapy approach, aimed to reduce the incidence of phlebitis is a valuable clinical and research goal.

Aim: To evaluate the safety and efficacy of oral versus intravenous (IV) Amiodarone in the treatment of AF of recent onset (duration < 48 h).

详细描述

Atrial fibrillation (AF) is the most common heart rhythm abnormality worldwide. Three therapeutic goals should be considered for each patient: Rate control, maintenance of sinus rhythm and prevention of thromboembolism. In managing AF, numerous antiarrhythmic drugs have been used. Intravenous amiodarone is a class III antiarrhythmic agent which has been reported to be safe and most effective in various clinical settings, without an associated increase in mortality rate. In most of the cases, the method of administration is via peripheral infusion. Phlebitis is the most common complication with peripheral infusion of amiodarone. Phlebitis adversely affects patient care; it may interfere with the continued infusion of amiodarone, necessitate insertion of another peripheral intravenous or central catheter, and extend hospitalization. Furthermore, patients who develop phlebitis, experience pain, swelling, and inflammation. Phlebitis can be prevented by oral administration.

The goal of the proposed study is to evaluate the incidence rate of phlebitis following IV administration of amiodarone and to investigate whether the oral administration of amiodarone in patients with recent onset AF (duration < 48 h), is safer than, and as efficient as, the IV administration of the same drug in the ICCU and ICU setting.

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
None

入排标准

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

入选标准

  • Over 18 years of age,
  • Patients who will be admitted to the ICCU / ICU wards
  • Patients with recent onset of atrial fibrillation (duration < 48h).

排除标准

  • Age < 18 years
  • Baseline systolic blood pressure < 100 mm/hg
  • Known thyroid disease
  • Serum potassium < 3.5 mmol/l
  • Pretreatment with amiodarone
  • Pregnant or lactating women.
  • Participation in other clinical trial.

研究组 & 干预措施

oral amiodarone, group A

Experimental

oral amiodarone 400 mg three times a day for 2 days

干预措施: Amiodarone (Drug)

IV amiodarone, Group B

Experimental

Amiodarone:

IV loading of 300 mg for 30 min in 100cc glucose 5% IV infusion with 900 mg/24h in 1000cc glucose 5%

干预措施: Amiodarone (Drug)

结局指标

主要结局

Incidence rate of phlebitis

时间窗: during 24 h

For detection of eventual amiodarone induced phlebitis the site of venous access will be examined 30 min, 3, 6, 12, 24 h after drug administration by one of the investigators

次要结局

  • Cumulative incidence of restored sinus rhythm(During 48h)
  • incidence of hypotension(during 24 h)

研究者

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

lilach shema

Coordinator, Quality Assurance Unit

Western Galilee Hospital-Nahariya

研究点 (1)

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