TOADS Study: TO Assess Death From Septic Shock.

Septic Shock Clinical Trial

— TOADS  

Official title:

Epidemiological Survey of Death Modalities in Patients With Septic Shock Referred to French Intensive Care Units: TOADS Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02547467
• Other study ID #: 49RC14_0223
• Status: Not yet recruiting
• Phase: N/A
• First received: July 8, 2015
• Last updated: September 9, 2015
• Start date: September 2015
• Est. completion date: May 2016

Study information

• Verified date: September 2015
• Source: University Hospital, Angers
• Contact: Pierre ASFAR, MD-PhD
• Phone: +33(0)241353815
• Email: piasfar[@]chu-angers.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 340
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Other:
• epidemiologic study
There is no intervention as it is a pure observational study for epidemiologic survey.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Angers	Laboratoire français de Fractionnement et de Biotechnologies

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome of this study is to identify the reasons of death of patients with septic shock via a questionnaire.	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	No