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OpenTrials
Completed

NCT Number: NCT01999829

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

citrate of caffeine

Drug

Placebo

Drug

Primary outcomes

  1. Decrease of 50 % of the incidence of atrial fibrillation

    Time frame: 24 MONTHS

Secondary outcomes

  1. decrease in the use of anti-arrhythmic resuscitation

    Time frame: 24 MONTHS

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2013
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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