Management of Paroxystic Atrial Fibrillation in French Intensive Care Units (PAF-ICU)

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

Study Overview

• Status: Completed
• Conditions: ICU Patients; New Onset Atrial Fibrillation

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.

• Study Type: Observational
• Enrollment (Actual): 742

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU
  • Angers, France
    • CHU
  • Argenteuil, France
    • CH
  • Besançon, France
    • CHU
  • Bordeau, France
    • CHU
  • Bourgoin-Jallieu, France
    • CH
  • Brest, France
    • Hopital D'Instruction Des Armees
  • Cholet, France
    • CH
  • Clermont-Ferrand, France
    • CHU
  • Dax, France
    • CH
  • Dijon, France
    • CHU
  • Eaubonne, France
    • CH
  • Grenoble, France
    • CHU
  • Lille, France
    • CHU
  • Lorient, France
    • Hôpital du Scorff
  • Marseille, France
    • APHM
  • Marseille, France
    • Hôpital Saint-Joseph
  • Marseille, France
    • La Timone APHM
  • Montpellier, France
    • Institut Regional Du Cancer de Montpellier
  • Nancy, France
    • CHU
  • Nantes, France
    • CHU
  • Nice, France
    • CHU
  • Nice, France
    • Clinique médicale les Sources
  • Nîmes, France
    • CHU
  • Paris, France
    • Hôpital Bichat
  • Paris, France
    • Hôpital Saint-Louis
  • Paris, France
    • Hopital Henri Mondor
  • Paris, France
    • Hôpital La Pitié Salpêtrière
  • Paris, France
    • Groupe Hospitalier Saint Joseph
  • Rennes, France
    • CHU
  • Saint-Etienne, France
    • CHU
  • Toulouse, France
    • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in French ICU

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Management of Atrial Fibrillation	All types of therapeutics used to manage atrial fibrillation are collected	ICU stay (until 28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac rhythm status	Type of rhythm : Normal (sinus rhythm), Atrial Fibrillation, Other disturbance	Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Blood pressure	Blood pressure. Unit : Millimeters of mercury	Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Heart rate	Heart rate. Unit : beats per minute	Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Cardiac output	Product of the heart rate (HR) and the stroke volume (SV), which is the volume of blood pumped from the ventricle per beat. Unit : L/min.	Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
ScvO2	Venous saturation. Unit : percentage	Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Vasopressors	Type of vasopressors used	Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Stroke	Occurrence of stroke during ICU stay	ICU Stay up to 28 days

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: French Society of Anesthesia and Intensive Care Medecine
• Investigators: Principal Investigator: Antoine Roquilly, CHU Nantes; Principal Investigator: Carole Ichai, CHU Nice; Principal Investigator: Jérôme Morel, Chu Saint-Etienne; Study Director: Jean-Michel Constantin, Réa Adulte CHU Clermont-Ferrand; Principal Investigator: 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 Nîmes; 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, Hopital 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, CHU Bordeaux; Principal Investigator: Cédric Bruel, CH Saint-Joseph Paris; Principal Investigator: Gaëtan Plantefeve, CH Argenteuil; Principal Investigator: Adrien Auvet, CH Dax; Principal Investigator: Enora Atchade, Hôpital Bichat; 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, CHU Toulouse; Principal Investigator: Armand Mekontso Dessap, Hôpital Henri Mondor APHP; Principal Investigator: Justine Perrot, CHU Dijon; Principal Investigator: Jibba Amraoui, Institut Regional Du Cancer de Montpellier; Principal Investigator: Matthias Garot, CHU Lille

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Actual): August 27, 2020
• Study Completion (Actual): August 27, 2020

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Rate control; ICU patients; New onset atrial fibrillation; Rhythm control; Paroxystic atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PAF-ICU - RNI 2018 CONSTANTIN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No