Abdominal SepsiS Study: Epidemiology of Etiology and Outcome (AbSeS)

June 28, 2017 updated by: European Society of Intensive Care Medicine
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • All Centres From All Over the World Willing to Contribute Are Welcome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive, adult ICU patients diagnosed with IAI- intra-abdominal infection (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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
One Group
This is a prospective observational study, aimed at collecting an adequate dataset on a large cohort of patients admitted to a large number of ICUs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical response
Time Frame: Clinical response at 3 days
Clinical response at 3 days
Clinical response
Time Frame: Clinical response at 7 days
Clinical response at 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within the first week
Length of hospitalization
Time Frame: up to 6 months
Length of ICU stay
up to 6 months
Mortality
Time Frame: During the 6 month study period
Survival status at discharge
During the 6 month study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Society of Intensive Care Medicine

Investigators

  • Principal Investigator: Stijn BLOT, University Hospital Ghent, Dept. of Internal Medicine
  • Principal Investigator: Dirk VOGELAERS, University Hospital Ghent, Dept. of Internal Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 2, 2017

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 8, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Actual)

June 29, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABSES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intra-Abdominal Infections

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe