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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
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 26, 2013
Last Updated
March 13, 2017
Sponsor
Assistance Publique Hopitaux De Marseille
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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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