Management of Paroxystic Atrial Fibrillation in French Intensive Care Units

Completed

• Conditions: ICU Patients; New Onset Atrial Fibrillation

• Registration Number: NCT03977883
• Lead Sponsor: University Hospital, Clermont-Ferrand

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 Timeline

• Study Start: 2019-05-13
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-06
• Primary Completion: 2020-08-27
• Study Completion: 2020-08-27
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 742

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Management of Atrial Fibrillation	ICU stay (until 28 days)	All types of therapeutics used to manage atrial fibrillation are collected

Secondary Outcome Measures

Name	Time	Method
Blood pressure	Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation	Blood pressure. Unit : Millimeters of mercury
Vasopressors	Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation	Type of vasopressors used
Stroke	ICU Stay up to 28 days	Occurrence of stroke during ICU stay
Cardiac rhythm status	Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation	Type of rhythm : Normal (sinus rhythm), Atrial Fibrillation, Other disturbance
Heart rate	Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation	Heart rate. Unit : beats per minute
Cardiac output	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	Before, 5 minutes, 30 minutes, 1 hour, and 24 hours after atrial fibrillation	Venous saturation. Unit : percentage

Trial Locations

Locations (14)

CH; 🇫🇷 Eaubonne, France

Hôpital d'Instruction des Armées; 🇫🇷 Brest, France

Hôpital du Scorff; 🇫🇷 Lorient, France

CHU; 🇫🇷 Toulouse, France

APHM; 🇫🇷 Marseille, France

La Timone APHM; 🇫🇷 Marseille, France

Clinique médicale les Sources; 🇫🇷 Nice, France

Institut Régional du Cancer de Montpellier; 🇫🇷 Montpellier, France

Hôpital La Pitié Salpêtrière; 🇫🇷 Paris, France

Hôpital Saint-Louis; 🇫🇷 Paris, France

Groupe Hospitalier Saint Joseph; 🇫🇷 Paris, France

Hôpital Saint-Joseph; 🇫🇷 Marseille, France

Hôpital Bichat; 🇫🇷 Paris, France

Hôpital Henri Mondor; 🇫🇷 Paris, France