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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03977883
Other study ID # PAF-ICU - RNI 2018 CONSTANTIN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 13, 2019
Est. completion date August 27, 2020

Study information

Verified date August 2021
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 742
Est. completion date August 27, 2020
Est. primary completion date August 27, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
France CHU Amiens
France CHU Angers
France CH Argenteuil
France CHU Besançon
France CHU Bordeau
France CH Bourgoin-Jallieu
France Hôpital d'Instruction des Armées Brest
France CH Cholet
France CHU Clermont-Ferrand
France CH Dax
France CHU Dijon
France CH Eaubonne
France CHU Grenoble
France CHU Lille
France Hôpital du Scorff Lorient
France APHM Marseille
France Hôpital Saint-Joseph Marseille
France La Timone APHM Marseille
France Institut Régional du Cancer de Montpellier Montpellier
France CHU Nancy
France CHU Nantes
France CHU Nice
France Clinique médicale les Sources Nice
France CHU Nîmes
France Groupe Hospitalier Saint Joseph Paris
France Hôpital Bichat Paris
France Hôpital Henri Mondor Paris
France Hôpital La Pitié Salpêtrière Paris
France Hôpital Saint-Louis Paris
France CHU Rennes
France CHU Saint-Etienne
France CHU Toulouse

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand French Society of Anesthesia and Intensive Care Medecine

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Management of Atrial Fibrillation All types of therapeutics used to manage atrial fibrillation are collected ICU stay (until 28 days)
Secondary 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
Secondary Blood pressure Blood pressure. Unit : Millimeters of mercury Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Secondary Heart rate Heart rate. Unit : beats per minute Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Secondary 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
Secondary ScvO2 Venous saturation. Unit : percentage Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Secondary Vasopressors Type of vasopressors used Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation
Secondary Stroke Occurrence of stroke during ICU stay ICU Stay up to 28 days
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