NCT02547467

Brief 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 .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

July 8, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 11, 2015

Status Verified

September 1, 2015

Enrollment Period

8 months

First QC Date

July 8, 2015

Last Update Submit

September 9, 2015

Conditions

Septic Shock

Keywords

mortality

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

epidemiologic studyOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients who had died of septic shock

You may qualify if:

  • Adult patient
  • Died of septic shock in the intensive care unit (ICU)
  • At least 6 hours of vasopressors

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shock, Septic

Interventions

Epidemiologic Studies

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Epidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Pierre ASFAR, MD-PhD

    University hospital, Angers, FRANCE

    STUDY DIRECTOR

Central Study Contacts

Pierre ASFAR, MD-PhD

CONTACT

+33(0)241353815piasfar@chu-angers.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2015

First Posted

September 11, 2015

Study Start

September 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 11, 2015

Record last verified: 2015-09