Management of Paroxystic Atrial Fibrillation in French Intensive Care Units

ICU Patients Clinical Trial

— PAF-ICU  

Official title:

Management of Paroxystic Atrial Fibrillation in French Intensive Care Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03977883
• Other study ID #: PAF-ICU - RNI 2018 CONSTANTIN
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• ICU Patients
• New Onset Atrial Fibrillation

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