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Intra-Abdominal InfectionsAbSeSNCT02442596

Abdominal SepsiS Study: Epidemiology of Etiology and Outcome

An observational study of Intra-Abdominal Infections, run by European Society of Intensive Care Medicine at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intra-Abdominal Infections
How many people
2,200 participants
Where
1 siteBelgium
Study dates
Jan 2016to 2 Apr 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • <18 yrs

Trial locations and contacts

1 site in 1 country.

Belgium1 site

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

    Brussels

Other trials in Belgium

About this study

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.

Read the 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

Keywords
Abdominal sepsis, Sepsis, Septic shock, Epidemiology, Etiology, Microbiology, Abdomen, Intra-abdominal, Infection, Gastrointestinal tract, Perforation, Peritonitis, Pancreas, Biliary tract, Megacolon
Medical subject headings
Intraabdominal Infections, Sepsis, Shock, Septic, Infections, Peritonitis, Megacolon

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02442596
Study groupRoleWhat they receive
One GroupThis 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical response

    Measured: Clinical response at 3 days

  2. Clinical response

    Measured: Clinical response at 7 days

Secondary outcomes (3)

  1. Surgical revision

    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.

    Measured: within the first week

  2. Length of hospitalization

    Length of ICU stay

    Measured: up to 6 months

  3. Mortality

    Survival status at discharge

    Measured: During the 6 month study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2015 (estimated)
  2. Study startJan 2016
  3. Primary completion1 Apr 2017
  4. Study completion2 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02442596
Sponsor's protocol ID
ABSES
Acronym
AbSeS
Status last verified
Jun 2017
First submitted
5 May 2015
Last updated
29 Jun 2017
Results posted
No
Data monitoring committee
No

Publications

  • Marshall JC. Intra-abdominal infections. Microbes Infect. 2004 Sep;6(11):1015-25. doi: 10.1016/j.micinf.2004.05.017.

    PubMed 15345234

  • De Waele JJ. Early source control in sepsis. Langenbecks Arch Surg. 2010 Jun;395(5):489-94. doi: 10.1007/s00423-010-0650-1. Epub 2010 Jun 2.

    PubMed 20517699

  • Schein M, Marshall J. Source control for surgical infections. World J Surg. 2004 Jul;28(7):638-45. doi: 10.1007/s00268-004-7505-2. Epub 2004 Jun 8.

    PubMed 15185005

  • Blot S, De Waele JJ. Critical issues in the clinical management of complicated intra-abdominal infections. Drugs. 2005;65(12):1611-20. doi: 10.2165/00003495-200565120-00002.

    PubMed 16060697

  • Rex JH. Candida in the peritoneum: passenger or pathogen? Crit Care Med. 2006 Mar;34(3):902-3. doi: 10.1097/01.CCM.0000202129.19154.64. No abstract available.

    PubMed 16505676

  • de Ruiter J, Weel J, Manusama E, Kingma WP, van der Voort PH. The epidemiology of intra-abdominal flora in critically ill patients with secondary and tertiary abdominal sepsis. Infection. 2009 Dec;37(6):522-7. doi: 10.1007/s15010-009-8249-6.

    PubMed 19669089

  • Swenson BR, Metzger R, Hedrick TL, McElearney ST, Evans HL, Smith RL, Chong TW, Popovsky KA, Pruett TL, Sawyer RG. Choosing antibiotics for intra-abdominal infections: what do we mean by "high risk"? Surg Infect (Larchmt). 2009 Feb;10(1):29-39. doi: 10.1089/sur.2007.041.

    PubMed 19226202

  • Dupont H, Friggeri A, Touzeau J, Airapetian N, Tinturier F, Lobjoie E, Lorne E, Hijazi M, Regimbeau JM, Mahjoub Y. Enterococci increase the morbidity and mortality associated with severe intra-abdominal infections in elderly patients hospitalized in the intensive care unit. J Antimicrob Chemother. 2011 Oct;66(10):2379-85. doi: 10.1093/jac/dkr308. Epub 2011 Jul 25.

    PubMed 21791444

  • Montravers P, Lepape A, Dubreuil L, Gauzit R, Pean Y, Benchimol D, Dupont H. Clinical and microbiological profiles of community-acquired and nosocomial intra-abdominal infections: results of the French prospective, observational EBIIA study. J Antimicrob Chemother. 2009 Apr;63(4):785-94. doi: 10.1093/jac/dkp005. Epub 2009 Feb 5.

    PubMed 19196742

  • Blot S, De Waele JJ, Vogelaers D. Essentials for selecting antimicrobial therapy for intra-abdominal infections. Drugs. 2012 Apr 16;72(6):e17-32. doi: 10.2165/11599800-000000000-00000.

    PubMed 22480338

Questions about this trial

What is this clinical trial studying?

An observational study of Intra-Abdominal Infections, run by European Society of Intensive Care Medicine at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical response (time frame: Clinical response at 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02442596, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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