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

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ClinicalTrials.gov Identifier: NCT03977883
Recruitment Status : Unknown
Verified May 2019 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
French Society of Anesthesia and Intensive Care Medecine
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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

Condition or disease
New Onset Atrial Fibrillation ICU Patients

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.

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Management of Paroxystic Atrial Fibrillation in French Intensive Care Units
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Management of Atrial Fibrillation [ Time Frame: ICU stay (until 28 days) ]
    All types of therapeutics used to manage atrial fibrillation are collected


Secondary Outcome Measures :
  1. Cardiac rhythm status [ Time Frame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation ]
    Type of rhythm : Normal (sinus rhythm), Atrial Fibrillation, Other disturbance

  2. Blood pressure [ Time Frame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation ]
    Blood pressure. Unit : Millimeters of mercury

  3. Heart rate [ Time Frame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation ]
    Heart rate. Unit : beats per minute

  4. Cardiac output [ Time Frame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation ]
    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.

  5. ScvO2 [ Time Frame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation ]
    Venous saturation. Unit : percentage

  6. Vasopressors [ Time Frame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation ]
    Type of vasopressors used

  7. Stroke [ Time Frame: ICU Stay up to 28 days ]
    Occurrence of stroke during ICU stay



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized in French ICU
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977883


Contacts
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Contact: Lise Laclautre +33 4 73 754963 promo_interne_drci@chu-clermontferrand.fr

Locations
Show Show 32 study locations
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
French Society of Anesthesia and Intensive Care Medecine
Investigators
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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 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 CHU Bordeaux
Principal Investigator: Cédric Bruel CH Saint-Joseph Paris
Principal Investigator: Antoine Roquilly CHU Nantes
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 CHU 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
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03977883    
Other Study ID Numbers: PAF-ICU - RNI 2018 CONSTANTIN
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
New onset atrial fibrillation
Paroxystic atrial fibrillation
ICU patients
Rate control
Rhythm control
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes