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.
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
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
- 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
- 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 group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
Measured: Clinical response at 3 days
Clinical response
Measured: Clinical response at 7 days
Secondary outcomes (3)
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
Length of hospitalization
Length of ICU stay
Measured: up to 6 months
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.
- First posted13 May 2015 (estimated)
- Study startJan 2016
- Primary completion1 Apr 2017
- Study completion2 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Intra-Abdominal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- European Society of Intensive Care Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stijn BLOT, Principal investigator, University Hospital Ghent, Dept. of Internal MedicineDirk VOGELAERS, Principal investigator, University Hospital Ghent, Dept. of Internal Medicine
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 15345234De 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 20517699Schein 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 15185005Blot 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 16060697Rex 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 16505676de 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 19669089Swenson 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 19226202Dupont 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 21791444Montravers 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 19196742Blot 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal SepsiS Study: Epidemiology of Etiology and Outcome
- ClinicalTrials.gov ID
- NCT02442596
- Acronym / sponsor ID
- AbSeS / ABSES
- Conditions
- Intra-Abdominal Infections
- Keywords
- Abdominal sepsis, Sepsis, Septic shock, Epidemiology, Etiology, Microbiology, Abdomen, Intra-abdominal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,200 participants (actual)
- Lead sponsor
- European Society of Intensive Care MedicineUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 2 Apr 2017 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- <18 yrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical response
Time frame: Clinical response at 3 days
Clinical response
Time frame: Clinical response at 7 days
3 secondary outcomes
Surgical revision
Time frame: within the first week
Length of hospitalization
Time frame: up to 6 months
Mortality
Time frame: During the 6 month study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Background: PubMed 15345234Marshall JC. Intra-abdominal infections. Microbes Infect. 2004 Sep;6(11):1015-25. doi: 10.1016/j.micinf.2004.05.017.
- Background: PubMed 20517699De 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.
- Background: PubMed 15185005Schein 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.
- Background: PubMed 16060697Blot 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.
- Background: PubMed 16505676Rex 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.
- Background: PubMed 19669089de 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.
- Background: PubMed 19226202Swenson 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.
- Background: PubMed 21791444Dupont 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.
- Background: PubMed 19196742Montravers 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.
- Background: PubMed 22480338Blot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stijn BLOT principal investigator
University Hospital Ghent, Dept. of Internal Medicine
Dirk VOGELAERS principal investigator
University Hospital Ghent, Dept. of Internal Medicine
1 site in 1 country: see every site and its status.
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.