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

Phase 3

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: placebo; Drug: citrate of caffeine

• Registration Number: NCT01999829
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-26
• Study Start: 2013-10
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-03
• Status Verified: 2015-08
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
citrate of caffeine	citrate of caffeine	-

Primary Outcome Measures

Name	Time	Method
Decrease of 50 % of the incidence of atrial fibrillation	24 MONTHS

Secondary Outcome Measures

Name	Time	Method
decrease in the use of anti-arrhythmic resuscitation	24 MONTHS

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France