Abdominal SepsiS Study: Epidemiology of Etiology and Outcome

NCT02442596 | Completed

• 1 other identifier: ABSES
• Study Type: observational
• Target: 2,200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Clinical response

  Clinical response at 3 days

• Clinical response

  Clinical response at 7 days

Secondary Outcomes (3)

• Surgical revision

  within the first week

• Length of hospitalization

  up to 6 months

• Mortality

  During the 6 month study period

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• \<18 yrs

Sponsors & Collaborators

• European Society of Intensive Care Medicine: lead

Study Sites (1)

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

Brussels, Belgium

Location

Related Publications (10)

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

  PMID: 15345234 BACKGROUND

• 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.

  PMID: 20517699 BACKGROUND

• 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.

  PMID: 15185005 BACKGROUND

• 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.

  PMID: 16060697 BACKGROUND

• 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.

  PMID: 16505676 BACKGROUND

• 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.

  PMID: 19669089 BACKGROUND

• 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.

  PMID: 19226202 BACKGROUND

• 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.

  PMID: 21791444 BACKGROUND

• 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.

  PMID: 19196742 BACKGROUND

• 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.

  PMID: 22480338 BACKGROUND

MeSH Terms

Conditions

Intraabdominal Infections; Sepsis; Shock, Septic; Infections; Peritonitis; Megacolon

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Peritoneal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases

Study Officials

• Stijn BLOT

  University Hospital Ghent, Dept. of Internal Medicine

  PRINCIPAL INVESTIGATOR

• Dirk VOGELAERS

  University Hospital Ghent, Dept. of Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 13, 2015
• Study Start: January 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 2, 2017
• Last Updated: June 29, 2017

Record last verified: 2017-06

Locations

BE (1)