Clinical Trials Directory

Trials / Completed

CompletedNCT02442596

Abdominal SepsiS Study: Epidemiology of Etiology and Outcome

Status
Completed
Phase
Study type
Observational
Enrollment
2,200 (actual)
Sponsor
European Society of Intensive Care Medicine · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Timeline

Start date
2016-01-01
Primary completion
2017-04-01
Completion
2017-04-02
First posted
2015-05-13
Last updated
2017-06-29

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT02442596. Inclusion in this directory is not an endorsement.