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Abdominal Sepsis Study: Epidemiology of Etiology and Outcome

Q&A

What?

AbSeS (Abdominal Sepsis Study: Epidemiology of Etiology and Outcome) is a multinational, prospective, observational study on intra-abdominal infections (IAIs) in critically ill patients with a special emphasis on epidemiology and outcomes.

Why?

The specific objectives of this study are:

  • To investigate microbiology and/or drug resistance patterns related to:
    • Geographical region
    • Source of IAI
    • Origin of IAI
  • To describe physician’s antimicrobial prescription patterns related to a classification grid that stratifies IAIs according to disease expression, community or healthcare origin, and anatomical disruption.
  • To investigate outcomes (clinical response, need for surgical revision, length of hospitalisation, and mortality) related to:
    • Type of IAI
    • Severity of acute illness at time of diagnosis (SOFA score) and clinical response after 48-72 hrs
    • Processes of care
    • Pathogens involved and empirical antimicrobial coverage; special emphasis will be given, to coverage of multidrug resistant Enterobacteriaceae, Pseudomonas aeruginosa, enterococci and Candida species
    • Duration of antimicrobial therapy

When?

Data collection began on 1st January and will be completed on 31 December 2016.

What data is required?

A basic dataset is collected on all consecutive, adult ICU patients diagnosed with IAI (either as a primary diagnosis or as a complication during the ICU course) during a 6 months period and with a maximum of 15 cases per unit.

Field: Post-sepsis onset evaluations are planned at 72 hrs (change in disease severity), at 7 days (necessity for surgical revision), and at 28 days (survival status).

Do I need IRB approval?

National coordinators will obtain IRB approval for their centres.

How is the data that is collected managed?

All data is annonymised and cannot be linked to individual subjects. The data is stored securely and all procedures regarding data management will comply with EU directive on data protection 95/46/EC.

Who owns and can access the collected data? 

Each site investigator is responsible for his own data and may request an export of this  data after the database is locked. The request should be addressed to the Principal Investigator.

Is there any financial compensation?

No. Participation in the trial is completely voluntary. This study will provide important data on intra-abdominal infections.

What about authorship? 

Results from the trial will be published by the AbSeS nominated writing Committee. All National Coordinators (NC) will have their efforts recognised by being listed in the paper. Due to the potential high number of centres that we hope will include patients, we have to limit to two names of local collaborators (the lead investigator and the co-investigator). Along with the national coordinators, they will be acknowledged as collaborators in the authorship of the paper and as such, listed in Pubmed.

How do I participate?

Registration is now closed.

Any further Questions?

If you have additional questions regarding AbSeS, please contact abses@esicm.org.

Documents

• AbSeS Steering Committee

Protocol & CRF

National Coordinators

Data Ownership

• PRS Number

Media 

Interviews with PI Stijn Blot

 

Contact

For more information, please contact AbSeS@esicm.org.