Prevention of Atrial Fibrillation Following Valvular Replacement With Cardiopulmonary Bypass: a Prospective, Randomized Clinical Study Comparing Oral Caffeine With Placebo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Decrease of 50 % of the incidence of atrial fibrillation
研究概览
简要总结
Atrial fibrillation remains a major cause of morbidity following cardiac surgery with cardiopulmonary bypass. Many mechanisms have been implicated. Among then, adenosine, a strong endogenous vasodilating agent has been involved in cardiac surgery-induced atrial fibrillation, via A2A receptors modulation.
The effects of caffeine on the inducibility of atrial fibrillation are actually well-known, leading then to a significant reduction of atrial fibrillation. Moreover, a recent clinical study has demonstrated that coffee drinking was inversely associated with total and cause-specific mortality.
The investigators therefore examined the preventive effects of oral caffeine on valvular surgery with cardiopulmonary bypass-induced atrial fibrillation. The investigators also evaluated prospectively the influence of caffeine on adenosine plasma levels and A2A adenosine receptors modulation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age = 18 years
- •Surgery valvular settled(adjusted) (plasties or aortic replacement, mitral, tricuspid or mixed), under CEC
- •Period of weaning in caffeine: limitation of the consumption of coffee(café), tea, chocolate, in a cup the day before the intervention
- •Consent of the patients after information
排除标准
- •Pregnant or breast-feeding women
- •Women taking an oral contraception (half-life of the caffeine increased until 3 times)
- •Minors(miners) or adults under guardianship
- •Persons staying in a sanitary or social establishment
- •Not profitable persons of a national insurance scheme
- •Private persons of freedom
- •Persons requiring a surgery of replacement valvular as a matter of urgency
- •Patients having been treated(handled) by papaverine, dipyridamole, corticoids, immunosuppressors or antibiotics during six weeks preceding the date of inclusion
- •Weighty patient lower than 50 kg or upper to 100 kg or having a body mass index upper to 29 Kg / m2
- •Presence of an active infection, a chronic inflammatory pathology, a lung arterial high blood pressure
研究组 & 干预措施
citrate of caffeine
干预措施: citrate of caffeine (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Decrease of 50 % of the incidence of atrial fibrillation
时间窗: 24 MONTHS
次要结局
- decrease in the use of anti-arrhythmic resuscitation(24 MONTHS)