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ETOFIB: Evaluation and Monitoring of the Protocol Post Operative Atrial Fibrillation

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT05165862
Collaborator
(none)
54
Enrollment
1
Location
20.5
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objectives The aims of this study is to evaluate the efficacy and tolerance of our post-operative AF management protocol after cardiac surgery, including beta-blockers, digoxin, amiodarone.

Methods This study concerns patients From brest university Hospital who underwent cardiac surgery between November 2019 and November 2021. Patients with a previous history of atrial arrhythmias were excluded. The primary endpoint is assess effectiveness of service protocol to maintain cardiac frequency below. 110 bpm. The secondary endpoints included hemodynamic tolerance and outcomes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Background Atrial fibrillation (AF) is the most common complication after open heart surgery. Its reported incidence is about 30%, and it is associated with a significant increase rate of thromboembolic events, respiratory failure, a longer lenght of stay in hospital and mortality. (1 ;2) Gillinov's study has shown equivalent effectiveness of a rhythm control and rate control strategy, in AF patients after cardiac surgery, with increased side effects in patients treated with rhythm control agents. (3) The introduction of beta-blockers can be poorly tolerated hemodynamically in patients hospitalized in intensive care unit, unless untroducing a cardio-selective beta-blocker..

    Methods Patients who underwent a cardiac surgery from Novembre 2019 to Novembre 2021 were included. Patients with a previous history of atrial arrhythmias were excluded. The primary endpoint is assess effectiveness of service protocol to maintain cardiac frequency below. 110 bpm. The secondary endpoints included hemodynamic tolerance and outcomes.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    54 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation and Monitoring of the Protocol for the Management of Post Operative Atrial Fibrillation Based on Intravenous Beta-blockers in Cardiac Surgery
    Actual Study Start Date :
    Feb 1, 2020
    Actual Primary Completion Date :
    Oct 16, 2021
    Actual Study Completion Date :
    Oct 16, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Heart Rate [72 hours (3 days)]

      HR < 110 BPM

    Secondary Outcome Measures

    1. sinusal Rythm [72hours ( 3 days)]

      time to be back in sinusal rythm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • POAF after cardiac surgery non-opposition formulated
    Exclusion Criteria:
    • pregnant woman opposition hemodynamic unstability with inotropic drugs or CI<2 L/min/m2

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest - Service d'anesthésie-Réanimation Brest France 29200

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT05165862
    Other Study ID Numbers:
    • ETOFIB (29BRC20.0038)
    First Posted:
    Dec 21, 2021
    Last Update Posted:
    Dec 21, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Dec 21, 2021