Abdominal SepsiS Study: Epidemiology of Etiology and Outcome

Intra-Abdominal Infections Clinical Trial

— AbSeS  

Official title:

Abdominal SepsiS Study: Epidemiology of Etiology and Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442596
• Other study ID #: ABSES
• Status: Completed
• Phase: N/A
• First received: May 5, 2015
• Last updated: June 28, 2017
• Start date: January 2016
• Est. completion date: April 2, 2017

Study information

• Verified date: June 2017
• Source: European Society of Intensive Care Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2200
• Est. completion date: April 2, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intra-Abdominal Infections
• Intraabdominal Infections
• Sepsis

Locations

Country	Name	City	State
Belgium	All Centres From All Over the World Willing to Contribute Are Welcome	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
European Society of Intensive Care Medicine

Country where clinical trial is conducted

Belgium, 

References & Publications (10)

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. — View Citation

Blot S, De Waele JJ. Critical issues in the clinical management of complicated intra-abdominal infections. Drugs. 2005;65(12):1611-20. Review. — View 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. — View 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. Review. — View Citation

Dupont H, Friggeri A, Touzeau J, Airapetian N, Tinturier F, Lobjoie E, Lorne E, Hijazi M, Régimbeau 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. — View Citation

Marshall JC. Intra-abdominal infections. Microbes Infect. 2004 Sep;6(11):1015-25. Review. — View 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. — View Citation

Rex JH. Candida in the peritoneum: passenger or pathogen? Crit Care Med. 2006 Mar;34(3):902-3. — View Citation

Schein M, Marshall J. Source control for surgical infections. World J Surg. 2004 Jul;28(7):638-45. Epub 2004 Jun 8. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response		Clinical response at 3 days
Primary	Clinical response		Clinical response at 7 days
Secondary	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.	within the first week
Secondary	Length of hospitalization	Length of ICU stay	up to 6 months
Secondary	Mortality	Survival status at discharge	During the 6 month study period