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Abdominal SepsiS Study: Epidemiology of Etiology and Outcome

Abdominal SepsiS Study: Epidemiology of Etiology and Outcome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02442596
Acronym
AbSeS
Enrollment
2200
Registered
2015-05-13
Start date
2016-01-31
Completion date
2017-04-02
Last updated
2017-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-Abdominal Infections

Keywords

Abdominal sepsis, Sepsis, Septic shock, Epidemiology, Etiology, Microbiology, Abdomen, Intra-abdominal, Infection, Gastrointestinal tract, Perforation, Peritonitis, Pancreas, Biliary tract, Megacolon

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

Interventions

None listed

Sponsors

European Society of Intensive Care Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Clinical responseClinical response at 3 days

Secondary

MeasureTime frameDescription
Surgical revisionwithin the first weekFor 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 hospitalizationup to 6 monthsLength of ICU stay
MortalityDuring the 6 month study periodSurvival status at discharge

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026