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TerminatedNCT03280992CASCUpdated Dec 2, 2021

Community Acquired Sepsis Cohort

An observational study in Severe Septic Syndrome and Septic Shock, sponsored by Rennes University Hospital. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-02.

Sponsored by Rennes University Hospital · Observational

Why this study was terminated
Study not feasible in practise
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
796
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this project is to constitute a prospective cohort of all the patients presenting to the adult emergencies of the University Hospital Centre (CHU) of Rennes for a septic syndrome of community origin.

Read the detailed description

Severe septic syndrome (SSG) and septic shock (CS) are two frequent and serious complications of infectious diseases. In this context, the optimization of the management of septic patients from their reception in the emergency services must be a priority. However there are no predictors of progression or severity in patients admitted to emergencies despite the recommendations emphasizing the need for screening and early therapeutic management. Many scores have been proposed for intensive care unit but they remain difficult to extrapolate to other services because they are very comprehensive and require information that is difficult to obtain for emergency physicians.

02

Conditions studied

  • Severe Septic Syndrome
  • Septic Shock
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient with a community infectious diseases

Inclusion criteria

  • Patient older than 18 years old
  • Patient hospitalized during the study period for community infectious diseases at the CHU of Rennes

Exclusion criteria

Exclusion Criteria:

  • Written objection from the patient to the computer processing of his data
  • Pregnant women
  • Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
796 participants (actual)
Target follow-up
3 Months
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. Assessment of morbidity in patients with septic syndrome of community origin

    Study of prognostic factors

    Time frame: Day 90

  2. Internal validity, severity score

    Time frame: Day 90

  3. Internal validity, triage score by orientation nurses

    Time frame: Day 90

  4. Study of the prognostic factors of patients with septic syndrome of community origin in terms of mortality

    Time frame: Day 90

06

Study locations

1 site
  • CHU de Rennes
    Rennes, 35033, France
07

Registry details

Key details

Study ID
NCT03280992
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Mar 2, 2016
Primary completion
Aug 27, 2018
Completion
Aug 27, 2018
Last update
Dec 2, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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