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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01943747
Other study ID # IMPRESS
Secondary ID
Status Completed
Phase N/A
First received September 12, 2013
Last updated August 19, 2014
Start date November 2013
Est. completion date January 2014

Study information

Verified date August 2014
Source European Society of Intensive Care Medicine
Contact n/a
Is FDA regulated No
Health authority Belgium: European Society of Intensive Care Medicine
Study type Observational

Clinical Trial Summary

To mark 10 years of the Surviving Sepsis Campaign (SSC), and timed to coincide with World Sepsis Day, on September 13, 2013, the SSC, ESICM and SCCM will be conducting an international point prevalence study of severe sepsis and septic shock. The goal of this project is to determine the world wide burden of severe sepsis and define current practices of sepsis care internationally. The study is a simple data collection exercise for patients presenting with either severe sepsis or septic shock on World Sepsis Day.


Description:

De--‐identified patient--‐level data will be collected on patients presenting to a participating intensive care unit or emergency department with severe sepsis or septic shock over a 24 hour period from 00:00 to 24:00 November 07, 2013. De--‐identified data that is already collected as part of routine clinical care will be collected for this study. Data to be collected includes hospital and ICU characteristics, patient characteristics, severity of illness, and adherence to SSC bundle elements and mortality. It will take between 30--‐60 minutes to collect and enter data for each patient admitted with severe sepsis or septic shock over the 24 hours study period.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date January 2014
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

To be eligible patients must have all of the following:

- Must be admitted or transferred to either the ED or an Intensive Care Unit.

- Have a high clinical suspicion of an infection

- Have sepsis as defined by an infection together with two or more SIRS criteria

- Evidence of acute organ dysfunction and/or Shock.

Exclusion Criteria:

- Patients less than 18 years of age

- Patients in whom the sepsis has been present from before the beginning of the study period

- Any patients previously included in the study during the same study period

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium All centres willing to contribute are welcome. Brussels

Sponsors (2)

Lead Sponsor Collaborator
European Society of Intensive Care Medicine Society of Critical Care Medicine (SCCM)

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other Length of Stay in the Hospital one week No
Primary 28-Day Mortality one week No
Secondary Organ Failure one week No
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