Study on the Frequency of de Novo Atrial Fibrillation in Septic Shock in Medical Intensive Care

Atrial Fibrillation Clinical Trial

— FACS  

Official title:

Prospective Study on the Frequency of de Novo Atrial Fibrillation in Septic Shock in Medical Intensive Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856191
• Other study ID #: QUENOT 2010
• Status: Completed
• Phase: N/A
• First received: August 2, 2016
• Last updated: August 3, 2016
• Start date: January 2011

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The aim of this pilot study is to determine, as exhaustively as possible thanks to the continuous and precise recording of heart rhythm, the frequency of de novo atrial fibrillation in septic shock, which is currently unknown, and to identify specific factors that could be associated with the condition. These will be investigated more precisely in a future study. This constitutes the first step in a reflection on the management of Cardiac Arrhythmia by Atrial fibrillation (ACFA) in septic shock in Medical Intensive Care, known as a major prognostic factor for morbimortality, but for which management is uncertain in the absence of reference data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients in septic shock (defined as hypotension that is not reversed by fluid resuscitation and requires the use of vasopressor agents) hospitalized in Medical intensive care

• Patients with national health insurance cover

• Age: at least 18 years with no upper limit

Exclusion Criteria:

• Transferred from another intensive care unit for septic shock

• Adults under guardianship

• History of atrial fibrillation

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Atrial Fibrillation
• Septic Shock
• Shock
• Shock, Septic

Intervention

Other:
• Holter

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation diagnosed on a Holter recording		Over 7 days following the onset of septic shock, or until death or discharge, if one of these events occurs in the 7 days following the onset of the shock.	No