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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999829
• Other study ID #: 2013-23
• Secondary ID: 2013-23
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2013
• Last updated: March 13, 2017
• Start date: October 2013
• Est. completion date: June 2016

Study information

• Verified date: August 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• citrate of caffeine

• placebo

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of 50 % of the incidence of atrial fibrillation		24 MONTHS
Secondary	decrease in the use of anti-arrhythmic resuscitation		24 MONTHS