Prevention of Atrial Fibrillation Following Valvular Replacement With Cardiopulmonary Bypass: a Prospective, Randomized Clinical Study Comparing Oral Caffeine With Placebo
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
citrate of caffeine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
citrate of caffeine
placebo
Arm Description
Outcomes
Primary Outcome Measures
Decrease of 50 % of the incidence of atrial fibrillation
Secondary Outcome Measures
decrease in the use of anti-arrhythmic resuscitation
Full Information
NCT ID
NCT01999829
First Posted
September 26, 2013
Last Updated
March 13, 2017
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01999829
Brief Title
Prevention of Atrial Fibrillation Following Valvular Replacement With Cardiopulmonary Bypass: a Prospective, Randomized Clinical Study Comparing Oral Caffeine With Placebo
Official Title
Prevention of Atrial Fibrillation Following Valvular Replacement With Cardiopulmonary Bypass: a Prospective, Randomized Clinical Study Comparing Oral Caffeine With Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
citrate of caffeine
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
citrate of caffeine
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Decrease of 50 % of the incidence of atrial fibrillation
Time Frame
24 MONTHS
Secondary Outcome Measure Information:
Title
decrease in the use of anti-arrhythmic resuscitation
Time Frame
24 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LOIC MONDOLONI
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
29702502
Citation
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.
Results Reference
derived
Learn more about this trial
Prevention of Atrial Fibrillation Following Valvular Replacement With Cardiopulmonary Bypass: a Prospective, Randomized Clinical Study Comparing Oral Caffeine With Placebo
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