NCT02856191

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
Last Updated

August 4, 2016

Status Verified

July 1, 2016

Enrollment Period

8 months

First QC Date

August 2, 2016

Last Update Submit

August 3, 2016

Conditions

Septic ShockAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Septic shock

OTHER
Other: Holter

Interventions

HolterOTHER
Septic shock

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Transferred from another intensive care unit for septic shock
  • Adults under guardianship
  • History of atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Conditions

Shock, SepticAtrial Fibrillation

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockArrhythmias, CardiacHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 4, 2016

Study Start

January 1, 2011

Primary Completion

September 1, 2011

Last Updated

August 4, 2016

Record last verified: 2016-07

Locations

FR(1)