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Completed

NCT Number: NCT03977883

Management of Paroxystic Atrial Fibrillation in French Intensive Care Units

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Management of Atrial Fibrillation

    Time frame: ICU stay (until 28 days)

    All types of therapeutics used to manage atrial fibrillation are collected

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • French Society of Anesthesia and Intensive Care Medecine

Registry information

Acronym: PAF-ICU

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 6, 2019
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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