Prevention of Atrial Fibrillation Following Valvular Replacement With Cardiopulmonary Bypass: a Prospective, Randomized Clinical Study Comparing Oral Caffeine With Placebo

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique Hopitaux De Marseille
• Treatments: Caffeine; Citric Acid

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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