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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

Tracking Information
First Submitted Date May 29, 2019
First Posted Date June 6, 2019
Last Update Posted Date June 6, 2019
Actual Study Start Date May 13, 2019
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2019)
Management of Atrial Fibrillation [ Time Frame: ICU stay (until 28 days) ]
All types of therapeutics used to manage atrial fibrillation are collected
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 5, 2019)
  • 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
  • Blood pressure [ Time Frame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation ]
    Blood pressure. Unit : Millimeters of mercury
  • Heart rate [ Time Frame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation ]
    Heart rate. Unit : beats per minute
  • 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.
  • ScvO2 [ Time Frame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation ]
    Venous saturation. Unit : percentage
  • Vasopressors [ Time Frame: Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation ]
    Type of vasopressors used
  • Stroke [ Time Frame: ICU Stay up to 28 days ]
    Occurrence of stroke during ICU stay
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Management of Paroxystic Atrial Fibrillation in French Intensive Care Units
Official Title Management of Paroxystic Atrial Fibrillation in French Intensive Care Units
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients hospitalized in French ICU
Condition
  • New Onset Atrial Fibrillation
  • ICU Patients
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 5, 2019)
2500
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2019
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03977883
Other Study ID Numbers PAF-ICU - RNI 2018 CONSTANTIN
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor University Hospital, Clermont-Ferrand
Collaborators French Society of Anesthesia and Intensive Care Medecine
Investigators
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
PRS Account University Hospital, Clermont-Ferrand
Verification Date May 2019