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

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase

Completed

Phase 3

Conditions

Atrial Fibrillation

Treatments

Drug: citrate of caffeine

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01999829

2013-23 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

110 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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