Clinical trial NCT03977883: Management of Paroxystic Atrial Fibrillation in French Intensive Care Units
Official title: Management of Paroxystic Atrial Fibrillation in French Intensive Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: New Onset Atrial Fibrillation
ICU Patients
Keywords: New onset atrial fibrillation
Paroxystic atrial fibrillation
ICU patients
Rate control
Rhythm control
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: French Society of Anesthesia and Intensive Care Medecine
First posted: 2019-06-06
Enrollment: 742
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in French ICU

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

Detailed description: Atrial fibrillation (AF) is a common arrhythmia in the ICU and is associated with significant morbidity. However, curative treatment remains unclearly established. In fact, there are no specific recommendations for new onset atrial fibrillation in ICU and only few studies have assessed this topic.

The PAF-ICU trial is an observational, prospective, multicenter, transversal trial. The main objective is to evaluate the management of paroxytic atrial fibrillation that occur in ICU.

The investigators want to document 2500 episodes of paroxystic atrial fibrillation in 50 ICU centers. In each center, the episodes are included consecutively until the required 50 episodes are obtained for each center.

A patient can present several episodes and each episode can be included in the study. A new episode is considered as such if it occurs more than one hour after the previous episode.

The follow-up period for each patient corresponds to the ICU stay.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Management of Atrial Fibrillation
timeFrame: ICU stay (until 28 days)
Secondary outcomes:
measure: Cardiac rhythm status
timeFrame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
measure: Blood pressure
timeFrame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
measure: Heart rate
timeFrame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
measure: Cardiac output
timeFrame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
measure: ScvO2
timeFrame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
measure: Vasopressors
timeFrame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
measure: Stroke
timeFrame: ICU Stay up to 28 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU
city: Angers
country: France
facility: CHU
city: Argenteuil
country: France
facility: CH
city: Besançon
country: France
facility: CHU
city: Bordeau
country: France
facility: CHU
city: Bourgoin-Jallieu
country: France
facility: CH
city: Brest
country: France
facility: Hôpital d'Instruction des Armées
city: Cholet
country: France
facility: CH
city: Clermont-Ferrand
country: France
facility: CHU
city: Dax
country: France
facility: CH
city: Dijon
country: France
facility: CHU
city: Eaubonne
country: France
facility: CH
city: Grenoble
country: France
facility: CHU
city: Lille
country: France
facility: CHU
city: Lorient
country: France
facility: Hôpital du Scorff
city: Marseille
country: France
facility: APHM
city: Marseille
country: France
facility: Hôpital Saint-Joseph
city: Marseille
country: France
facility: La Timone APHM
city: Montpellier
country: France
facility: Institut Régional du Cancer de Montpellier
city: Nancy
country: France
facility: CHU
city: Nantes
country: France
facility: CHU
city: Nice
country: France
facility: CHU
city: Nice
country: France
facility: Clinique médicale les Sources
city: Nîmes
country: France
facility: CHU
city: Paris
country: France
facility: Groupe Hospitalier Saint Joseph
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Hôpital Henri Mondor
city: Paris
country: France
facility: Hôpital La Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Rennes
country: France
facility: CHU
city: Saint-Etienne
country: France
facility: CHU
city: Toulouse
country: France
facility: CHU
Study officials:
affiliation: Réa Adulte CHU Clermont-Ferrand
name: Jean-Michel Constantin
role: STUDY_DIRECTOR
affiliation: Neuro-Réa CHU Clermont-Ferrand
name: Bernard Cosserant
role: PRINCIPAL_INVESTIGATOR
affiliation: RMC CHU Clermont-Ferrand
name: Raiko Blondonnet
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Lille
name: Eric Kipnis
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Besancçon
name: Jonathan Paillot
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de la Réunion
name: Charles Vidal
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Nimes
name: Laurent Muller
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Cholet
name: Johann Auchabie
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Lorient
name: Guillaume Grillet
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: Philippe Seguin
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Nancy
name: Philippe Guerci
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Saint-Joseph - Marseille
name: Bernard Lalanne
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Nord - APHM
name: Marc Leone
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Bourgoin-Jallieu
name: Stanislas Ledochowski
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Saint-Louis - APHP
name: Matthieu Legrand
role: PRINCIPAL_INVESTIGATOR
affiliation: La Timone APHM
name: Jeremy Bourenne
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Grenoble
name: Michel Durand
role: PRINCIPAL_INVESTIGATOR
affiliation: La Pitié Sapêtrière
name: Antoine Monsel
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Mathieu Guilbart
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Matthieu Biais
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Saint-Joseph Paris
name: Cédric Bruel
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Antoine Roquilly
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Argenteuil
name: Gaëtan Plantefeve
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU SAINT-ETIENNE
name: Jérôme Morel
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU NICE
name: Carole Ichai
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Dax
name: Adrien Auvet
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Bichat
name: Enora Atchade
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Angers
name: Sigismond Lasocki
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Les Sources Nice
name: Pierre-Eric Danin
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital d'Instruction des Armées de Brest
name: Marc Danguy Des Deserts
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Simone Veil - CH d'Eaubonne
name: Evelina Ochin Salatova
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Toulouse
name: Antoine Rouget
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Henri Mondor APHP
name: Armand Mekontso Dessap
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Dijon
name: Justine Perrot
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Régional du Cancer de Montpellier
name: Jibba Amraoui
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Lille
name: Matthias Garot
role: PRINCIPAL_INVESTIGATOR
References: