- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02547467
TOADS Study: TO Assess Death From Septic Shock. (TOADS)
September 9, 2015 updated by: University Hospital, Angers
Epidemiological Survey of Death Modalities in Patients With Septic Shock Referred to French Intensive Care Units: TOADS Study.
The aim of this study is to assess the causes of death in patients with septic shock in French intensive care units.
It is an epidemiologic and descriptive study .
Study Overview
Detailed Description
The purpose of this epidemiologic study is to describe with accuracy the reasons and causes of death in patients with septic shock during patients stay in intensive care units.
All deceased patients with primary diagnosis of septic shock will be included in this survey and patients baseline characteristics as well as the clinical and data at the time of patient's death will be recorded.
Study Type
Observational
Enrollment (Anticipated)
340
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Sampling Method
Non-Probability Sample
Study Population
Consecutive patients who had died of septic shock
Description
Inclusion Criteria:
- Adult patient
- Died of septic shock in the intensive care unit (ICU)
- At least 6 hours of vasopressors
Exclusion Criteria:
- Legally protected adult patient.
- Less than 6 hours of vasopressors
- Opposition to participation in the study expressed by the patient, family or person of trust
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The primary outcome of this study is to identify the reasons of death of patients with septic shock via a questionnaire.
Time Frame: Patients will be followed during their hospital stay, with a maximal follow up of 90 days
|
Recording of the context and the cause of death with a questionnaire
|
Patients will be followed during their hospital stay, with a maximal follow up of 90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Pierre ASFAR, MD-PhD, University hospital, Angers, FRANCE
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
September 1, 2015
Primary Completion (Anticipated)
May 1, 2016
Study Completion (Anticipated)
May 1, 2016
Study Registration Dates
First Submitted
July 8, 2015
First Submitted That Met QC Criteria
September 9, 2015
First Posted (Estimate)
September 11, 2015
Study Record Updates
Last Update Posted (Estimate)
September 11, 2015
Last Update Submitted That Met QC Criteria
September 9, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 49RC14_0223
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.
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