- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02856191
Study on the Frequency of de Novo Atrial Fibrillation in Septic Shock in Medical Intensive Care (FACS)
August 3, 2016 updated by: Centre Hospitalier Universitaire Dijon
Prospective Study on the Frequency of de Novo Atrial Fibrillation in Septic Shock in Medical Intensive Care
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Dijon, France, 21079
- Chu Dijon Bourgogne
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Septic shock
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Atrial fibrillation diagnosed on a Holter recording
Time Frame: 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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
August 2, 2016
First Submitted That Met QC Criteria
August 3, 2016
First Posted (Estimate)
August 4, 2016
Study Record Updates
Last Update Posted (Estimate)
August 4, 2016
Last Update Submitted That Met QC Criteria
August 3, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QUENOT 2010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Septic Shock
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German Center for Neurodegenerative Diseases (DZNE)University Hospital, BonnUnknownSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockGermany
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McMaster UniversityCanadian Institutes of Health Research (CIHR); The Physicians' Services Incorporated...Recruiting
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Assistance Publique - Hôpitaux de ParisCompletedSeptic Shock HyperdynamicFrance
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University Medicine GreifswaldUnknownSepsis Septic ShockGermany
-
Indonesia UniversityCompletedSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockIndonesia
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University of ZurichCompletedPatients in Septic ShockSwitzerland
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Centre Hospitalier Universitaire DijonCompleted
-
Mansoura UniversityUnknown
-
Rennes University HospitalTerminated
-
University Hospital, GrenobleCompletedImmunocompetent Patient on Septic ShockFrance
Clinical Trials on Holter
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University Hospital, LilleGroupement Interrégional de Recherche Clinique et d'Innovation; french patient...Not yet recruiting
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Centre Hospitalier Universitaire de Saint EtienneTerminatedCluster HeadacheFrance
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Assiut UniversityUnknown
-
Chang Gung Memorial HospitalNational Taiwan University Hospital; Chiayi Christian Hospital; Dalin Tzu Chi...CompletedIschemic StrokeTaiwan
-
Assiut UniversityNot yet recruitingPremature Ventricular Complex
-
Rigshospitalet, DenmarkActive, not recruitingHeart Diseases | Cardiovascular Diseases | Kidney Diseases | Renal Insufficiency, Chronic | Renal Insufficiency | Arrhythmias, Cardiac | Kidney Failure, ChronicDenmark
-
Helwan UniversityCompleted
-
University of Toledo Health Science CampusCompletedElectrocardiographyUnited States
-
Taipei Veterans General Hospital, TaiwanRecruitingIdiopathic Pulmonary FibrosisTaiwan