NCT05165862

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed
Last Updated

December 21, 2021

Status Verified

December 1, 2021

Enrollment Period

1.7 years

First QC Date

September 24, 2020

Last Update Submit

December 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Heart Rate

    HR \< 110 BPM

    72 hours (3 days)

Secondary Outcomes (1)

  • sinusal Rythm

    72hours ( 3 days)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

POAF after cardiac surgery, hospitalized in ICU

You may qualify if:

  • POAF after cardiac surgery non-opposition formulated

You may not qualify if:

  • pregnant woman opposition hemodynamic unstability with inotropic drugs or CI\<2 L/min/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest - Service d'anesthésie-Réanimation

Brest, 29200, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2020

First Posted

December 21, 2021

Study Start

February 1, 2020

Primary Completion

October 16, 2021

Study Completion

October 16, 2021

Last Updated

December 21, 2021

Record last verified: 2021-12

Locations