NCT01943747

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

August 20, 2014

Status Verified

August 1, 2014

Enrollment Period

Same day

First QC Date

September 12, 2013

Last Update Submit

August 19, 2014

Conditions

Severe SepsisSeptic Shock

Keywords

sepsissevere sepsisseptic shockinfectionorgan dysfunctionquality improvement

Outcome Measures

Primary Outcomes (1)

  • 28-Day Mortality

    one week

Secondary Outcomes (1)

  • Organ Failure

    one week

Other Outcomes (1)

  • Length of Stay in the Hospital

    one week

Eligibility Criteria

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

patients presenting with either severe sepsis or septic shock

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All centres willing to contribute are welcome.

Brussels, Belgium

Location

MeSH Terms

Conditions

SepsisShock, SepticInfections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Andrew RHODES, MD, PhD

    European Society of Intensive Care Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2013

First Posted

September 17, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2013

Study Completion

January 1, 2014

Last Updated

August 20, 2014

Record last verified: 2014-08

Locations

BE(1)