Skip to main content
OpenTrials
Completed

NCT Number: NCT02442596

Abdominal SepsiS Study: Epidemiology of Etiology and Outcome

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intra-Abdominal Infections Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Infections Inflammation Intestinal Diseases Intraabdominal Infections Megacolon Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Peritonitis Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

All Centres From All Over the World Willing to Contribute Are Welcome

Brussels, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Clinical response

    Time frame: Clinical response at 3 days

  2. Clinical response

    Time frame: Clinical response at 7 days

Secondary outcomes

  1. Surgical revision

    Time frame: 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.

  2. Length of hospitalization

    Time frame: up to 6 months

    Length of ICU stay

  3. Mortality

    Time frame: During the 6 month study period

    Survival status at discharge

Sponsors and collaborators

Lead sponsor

European Society of Intensive Care Medicine

Other

Registry information

Acronym: AbSeS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 13, 2015
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.