Clinical trial NCT02442596: Abdominal SepsiS Study: Epidemiology of Etiology and Outcome
Official title: Abdominal SepsiS Study: Epidemiology of Etiology and Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: European Society of Intensive Care Medicine
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Clinical response
timeFrame: Clinical response at 3 days
measure: Clinical response
timeFrame: Clinical response at 7 days
Secondary outcomes:
measure: Surgical revision
timeFrame: within the first week
measure: Length of hospitalization
timeFrame: up to 6 months
measure: Mortality
timeFrame: During the 6 month study period
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: All Centres From All Over the World Willing to Contribute Are Welcome
Study officials:
affiliation: University Hospital Ghent, Dept. of Internal Medicine
name: Stijn BLOT
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Ghent, Dept. of Internal Medicine
name: Dirk VOGELAERS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marshall JC. Intra-abdominal infections. Microbes Infect. 2004 Sep;6(11):1015-25. doi: 10.1016/j.micinf.2004.05.017.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.