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Completed

NCT Number: NCT05165862

Evaluation and Monitoring of the Protocol Post Operative Atrial Fibrillation

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.

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Key information

Conditions

Post Operative Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest - Service d'anesthésie-Réanimation

Brest, 29200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Heart Rate

    Time frame: 72 hours (3 days)

    HR < 110 BPM

Secondary outcomes

  1. sinusal Rythm

    Time frame: 72hours ( 3 days)

    time to be back in sinusal rythm

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Evaluation and Monitoring of the Protocol for the Management of Post Operative Atrial Fibrillation Based on Intravenous Beta-blockers in Cardiac Surgery

Acronym: ETOFIB

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2021
Registry last updated
Dec 21, 2021

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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