Post Operative Atrial FibrillationETOFIBNCT05165862
Evaluation and Monitoring of the Protocol Post Operative Atrial Fibrillation
An observational study of Post Operative Atrial Fibrillation, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Atrial Fibrillation
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2020to 16 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: POAF after cardiac surgery, hospitalized in ICU
Who may be able to join
- POAF after cardiac surgery non-opposition formulated
Who cannot join
- pregnant woman opposition hemodynamic unstability with inotropic drugs or CI<2 L/min/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation and Monitoring of the Protocol for the Management of Post Operative Atrial Fibrillation Based on Intravenous Beta-blockers in Cardiac Surgery
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.
Read the 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.
- Conditions
- Post Operative Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
HR < 110 BPM
Measured: 72 hours (3 days)
Secondary outcomes (1)
sinusal Rythm
time to be back in sinusal rythm
Measured: 72hours ( 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Feb 2020
- Primary completion16 Oct 2021
- Study completion16 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165862
- Sponsor's protocol ID
- ETOFIB (29BRC20.0038)
- Acronym
- ETOFIB
- Status last verified
- Dec 2021
- First submitted
- 24 Sep 2020
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Monitoring of the Protocol for the Management of Post Operative Atrial Fibrillation Based on Intravenous Beta-blockers in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05165862
- Acronym / sponsor ID
- ETOFIB / ETOFIB (29BRC20.0038)
- Conditions
- Post Operative Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 16 Oct 2021 (actual)
- Study completion
- 16 Oct 2021 (actual)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- POAF after cardiac surgery, hospitalized in ICU
Key inclusion criteria (1 listed)
- POAF after cardiac surgery non-opposition formulated
Key exclusion criteria (1 listed)
- pregnant woman opposition hemodynamic unstability with inotropic drugs or CI<2 L/min/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart Rate
Time frame: 72 hours (3 days)
HR < 110 BPM
1 secondary outcome
sinusal Rythm
Time frame: 72hours ( 3 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Atrial Fibrillation, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: 72 hours (3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.