NCT03977883

Brief Summary

The primary purpose of the study is to evaluate treatment of new onset atrial fibrillation in french ICU.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
742

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

32 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2020

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

May 29, 2019

Last Update Submit

August 24, 2021

Conditions

Keywords

New onset atrial fibrillationParoxystic atrial fibrillationICU patientsRate controlRhythm control

Outcome Measures

Primary Outcomes (1)

  • Management of Atrial Fibrillation

    All types of therapeutics used to manage atrial fibrillation are collected

    ICU stay (until 28 days)

Secondary Outcomes (7)

  • Cardiac rhythm status

    Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation

  • Blood pressure

    Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation

  • Heart rate

    Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation

  • Cardiac output

    Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation

  • ScvO2

    Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation

  • +2 more secondary outcomes

Eligibility Criteria

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

Patients hospitalized in French ICU

You may qualify if:

  • Age \> 18 years
  • Patient hospitalized in ICU
  • New onset atrial fibrillation

You may not qualify if:

  • Age \< 18 years
  • Parturient or breast-feeding woman
  • Persistent or permanent atrial fibrillation
  • Patients after cardiovascular or thoracic surgery
  • Patients with therapeutic limitations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

CHU

Amiens, France

Location

CHU

Angers, France

Location

CH

Argenteuil, France

Location

CHU

Besançon, France

Location

CHU

Bordeau, France

Location

CH

Bourgoin, France

Location

Hôpital d'Instruction des Armées

Brest, France

Location

CH

Cholet, France

Location

CHU

Clermont-Ferrand, France

Location

CH

Dax, France

Location

CHU

Dijon, France

Location

CH

Eaubonne, France

Location

CHU

Grenoble, France

Location

CHU

Lille, France

Location

Hôpital du Scorff

Lorient, France

Location

APHM

Marseille, France

Location

Hôpital Saint-Joseph

Marseille, France

Location

La Timone APHM

Marseille, France

Location

Institut Régional du Cancer de Montpellier

Montpellier, France

Location

CHU

Nancy, France

Location

CHU

Nantes, France

Location

CHU

Nice, France

Location

Clinique médicale les Sources

Nice, France

Location

CHU

Nîmes, France

Location

Groupe Hospitalier Saint Joseph

Paris, France

Location

Hôpital Bichat

Paris, France

Location

Hôpital Henri Mondor

Paris, France

Location

Hôpital La Pitié Salpêtrière

Paris, France

Location

Hôpital Saint-Louis

Paris, France

Location

CHU

Rennes, France

Location

CHU

Saint-Etienne, France

Location

CHU

Toulouse, France

Location

Related Publications (1)

  • Pardo E, Futier E, Muller L, Besch G, Vardon-Bounes F, Kipnis E, Lasocki S, Ledochowski S, Ochin E, Bourenne J, Grillet G, Auvet A, Mekontso Dessap A, Bruel C, Launey Y, Fiorillo M, Jabaudon M, Godet T, Mulliez A, Constantin JM; SFAR Research Network. Management of new-onset atrial fibrillation in critically ill patients: A national multicenter prospective cohort. Anaesth Crit Care Pain Med. 2025 Sep 26;45(1):101617. doi: 10.1016/j.accpm.2025.101617. Online ahead of print.

Study Officials

  • Jean-Michel Constantin

    Réa Adulte CHU Clermont-Ferrand

    STUDY DIRECTOR
  • Bernard Cosserant

    Neuro-Réa CHU Clermont-Ferrand

    PRINCIPAL INVESTIGATOR
  • Raiko Blondonnet

    RMC CHU Clermont-Ferrand

    PRINCIPAL INVESTIGATOR
  • Eric Kipnis

    CHU Lille

    PRINCIPAL INVESTIGATOR
  • Jonathan Paillot

    CHU Besancçon

    PRINCIPAL INVESTIGATOR
  • Charles Vidal

    CHU de la Réunion

    PRINCIPAL INVESTIGATOR
  • Laurent Muller

    CHU Nimes

    PRINCIPAL INVESTIGATOR
  • Johann Auchabie

    CH Cholet

    PRINCIPAL INVESTIGATOR
  • Guillaume Grillet

    CH Lorient

    PRINCIPAL INVESTIGATOR
  • Philippe Seguin

    CHU Rennes

    PRINCIPAL INVESTIGATOR
  • Philippe Guerci

    CHRU Nancy

    PRINCIPAL INVESTIGATOR
  • Bernard Lalanne

    Hôpital Saint-Joseph - Marseille

    PRINCIPAL INVESTIGATOR
  • Marc Leone

    Hôpital Nord - APHM

    PRINCIPAL INVESTIGATOR
  • Stanislas Ledochowski

    CH Bourgoin-Jallieu

    PRINCIPAL INVESTIGATOR
  • Matthieu Legrand

    Hôpital Saint-Louis - APHP

    PRINCIPAL INVESTIGATOR
  • Jeremy Bourenne

    La Timone APHM

    PRINCIPAL INVESTIGATOR
  • Michel Durand

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR
  • Antoine Monsel

    La Pitié Sapêtrière

    PRINCIPAL INVESTIGATOR
  • Mathieu Guilbart

    CHU Amiens

    PRINCIPAL INVESTIGATOR
  • Matthieu Biais

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR
  • Cédric Bruel

    CH Saint-Joseph Paris

    PRINCIPAL INVESTIGATOR
  • Antoine Roquilly

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR
  • Gaëtan Plantefeve

    CH Argenteuil

    PRINCIPAL INVESTIGATOR
  • Jérôme Morel

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR
  • Carole Ichai

    CHU NICE

    PRINCIPAL INVESTIGATOR
  • Adrien Auvet

    CH Dax

    PRINCIPAL INVESTIGATOR
  • Enora Atchade

    Hôpital Bichat

    PRINCIPAL INVESTIGATOR
  • Sigismond Lasocki

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR
  • Pierre-Eric Danin

    Clinique Les Sources Nice

    PRINCIPAL INVESTIGATOR
  • Marc Danguy Des Deserts

    Hôpital d'Instruction des Armées de Brest

    PRINCIPAL INVESTIGATOR
  • Evelina Ochin Salatova

    Hôpital Simone Veil - CH d'Eaubonne

    PRINCIPAL INVESTIGATOR
  • Antoine Rouget

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR
  • Armand Mekontso Dessap

    Hôpital Henri Mondor APHP

    PRINCIPAL INVESTIGATOR
  • Justine Perrot

    CHU Dijon

    PRINCIPAL INVESTIGATOR
  • Jibba Amraoui

    Institut Régional du Cancer de Montpellier

    PRINCIPAL INVESTIGATOR
  • Matthias Garot

    CHU Lille

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 29, 2019

First Posted

June 6, 2019

Study Start

May 13, 2019

Primary Completion

August 27, 2020

Study Completion

August 27, 2020

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations