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

NCT01999829 | Completed Phase 3

• 1 other identifier: 2013-23
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Decrease of 50 % of the incidence of atrial fibrillation

  24 MONTHS

Secondary Outcomes (1)

• decrease in the use of anti-arrhythmic resuscitation

  24 MONTHS

Study Arms (2)

citrate of caffeine

EXPERIMENTAL

Drug: citrate of caffeine

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

citrate of caffeine DRUG

citrate of caffeine

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

• Lagier D, Nee L, Guieu R, Kerbaul F, Fenouillet E, Roux N, Giorgi R, Theron A, Grisoli D, Gariboldi V, Collart F, Bruder N, Velly L, Guidon C. Peri-operative oral caffeine does not prevent postoperative atrial fibrillation after heart valve surgery with cardiopulmonary bypass: A randomised controlled clinical trial. Eur J Anaesthesiol. 2018 Dec;35(12):911-918. doi: 10.1097/EJA.0000000000000824.

  PMID: 29702502 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• LOIC MONDOLONI

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: December 3, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 14, 2017

Record last verified: 2015-08

Locations

FR (1)