Abdominal SepsiS Study: Epidemiology of Etiology and Outcome

Completed

• Conditions: Intra-Abdominal Infections

• Registration Number: NCT02442596
• Lead Sponsor: European Society of Intensive Care Medicine

Brief Summary

The aim of the project is to perform a multinational, prospective, observational study on IAIs (IntraAbdominal Infections) in critically ill patients; special emphasis will be given to epidemiology and outcomes.

Detailed Description

To investigate microbiology and/or drug resistance patterns related to: Geographical region, Source of IAI, Upper GI tract perforation (stomach \& duodenum), Lower GI tract perforation (jejunum, ileum, colon, rectum), Primary peritonitis, Peritoneal dialysis-related peritonitis, Intra-abdominal abscess, Pancreatic infection, Biliary tract infection, Typhlitis, Toxic megacolon.

To check the Origin of IAI: community-acquired, early-onset healthcare-associated, late-onset healthcare-associated.

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 hospitalization, and mortality) related to: Classification of IAI, Severity of acute illness at time of diagnosis (SOFA score) and clinical response after 48-72 hrs. (SOFA score), Processes of care (Time to 1st antimicrobial dose, Time to source control, Type of source control intervention (laparotomy, percutaneous drainage, high volume peritoneal lavage, restoration of anatomy and function), Need for (unplanned) surgical revision (uncontrolled infection source), Frequency of microbiological sampling and delay of results)), 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, Underlying conditions

Study Timeline

• Study First Submitted: 2015-05-05
• Study First Submitted QC: 2015-05-08
• Study First Posted: 2015-05-13
• Study Start: 2016-01
• Primary Completion: 2017-04-01
• Study Completion: 2017-04-02
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

• Adult (≥18 yrs. of age)
• IAI treated with percutaneous or surgical procedure
• ICU admission (the patient should either be admitted to the ICU because of abdominal sepsis or should be admitted in the ICU for other reasons and subsequently developed abdominal sepsis as a complication during the ICU course)
• Informed consent (if required by local ethics committee)

Exclusion Criteria

<18 yrs

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical response	Clinical response at 7 days

Secondary Outcome Measures

Name	Time	Method
Surgical revision	within the first week	For the abdominal sepsis cases that were managed with a surgical intervention (most of them), the need for a surgical revision (re-intervention) within the first week after the initial procedure is considered "failure of initial source control". The need for an additional surgical intervention within the first week will be assessed.
Length of hospitalization	up to 6 months	Length of ICU stay
Mortality	During the 6 month study period	Survival status at discharge

Trial Locations

Locations (1)

All Centres From All Over the World Willing to Contribute Are Welcome; 🇧🇪 Brussels, Belgium