Bloodstram Infections in ICU. Single Centre Observational Study.

Intensive Care Unit Clinical Trial

Official title:

Bloodstram Infections in Intensive Care Unit. A Single Centre Bacteriological Analysis Between 2007-2019.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04926935
• Other study ID #: 09
• Status: Completed
• Start date: January 1, 2007
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2021
• Source: Military Institute of Medicine, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hospital-acquired bloodstream infection (BSI) is serious care problem worldwide associated with significant morbidity and mortality. However, only few nationwide studies have focused on the incidence of BSI, and its results were often inconsistent.

The objective of this study was to analyze bloodstream infections in patients hospitalized in the intensive care unit of the tertiary, university hospital. Special attention was put on the etiology of the infections, the antimicrobial susceptibility/resistance of the isolated pathogens, as well as the incidence of central vein catheters infections in the analyzed population.

Data were collected in the intensive care unit of the Military Institute of Medicine, Warsaw, Poland, between January, 1, 2007 and December, 31, 2019.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3502
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients hospitalized in the ICU with clinically suspected infection.

Exclusion Criteria:

• none.

Related Conditions & MeSH terms

• Antibiotic Resistant Strain
• Bloodstream Infection
• Communicable Diseases
• Infection
• Intensive Care Unit
• Sepsis

Intervention

Diagnostic Test:
• Microbiological analysis of blood samples.
Microbiological analysis of blood samples collected from the patients with clinically suspected infection.

Locations

Country	Name	City	State
Poland	Department of Anesthesiology and Intensive Therapy	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Military Institute of Medicine, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (6)

de Kraker ME, Jarlier V, Monen JC, Heuer OE, van de Sande N, Grundmann H. The changing epidemiology of bacteraemias in Europe: trends from the European Antimicrobial Resistance Surveillance System. Clin Microbiol Infect. 2013 Sep;19(9):860-8. doi: 10.1111 — View Citation

Garrouste-Orgeas M, Timsit JF, Tafflet M, Misset B, Zahar JR, Soufir L, Lazard T, Jamali S, Mourvillier B, Cohen Y, De Lassence A, Azoulay E, Cheval C, Descorps-Declere A, Adrie C, Costa de Beauregard MA, Carlet J; OUTCOMEREA Study Group. Excess risk of d — View Citation

Goto M, Al-Hasan MN. Overall burden of bloodstream infection and nosocomial bloodstream infection in North America and Europe. Clin Microbiol Infect. 2013 Jun;19(6):501-9. doi: 10.1111/1469-0691.12195. Epub 2013 Mar 8. Review. — View Citation

Laupland KB, Lee H, Gregson DB, Manns BJ. Cost of intensive care unit-acquired bloodstream infections. J Hosp Infect. 2006 Jun;63(2):124-32. Epub 2006 Apr 18. — View Citation

Nielsen SL, Pedersen C, Jensen TG, Gradel KO, Kolmos HJ, Lassen AT. Decreasing incidence rates of bacteremia: a 9-year population-based study. J Infect. 2014 Jul;69(1):51-9. doi: 10.1016/j.jinf.2014.01.014. Epub 2014 Feb 25. — View Citation

Wilson J, Elgohari S, Livermore DM, Cookson B, Johnson A, Lamagni T, Chronias A, Sheridan E. Trends among pathogens reported as causing bacteraemia in England, 2004-2008. Clin Microbiol Infect. 2011 Mar;17(3):451-8. doi: 10.1111/j.1469-0691.2010.03262.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results of microbiological analysis.	Results of the microbiological analysis of the blood samples collected from patients with clinically suspected infections hospitalized in the ICU during the study period.	After completion of the microbiological analysis, up to 72 hours.
Primary	Isolated pathogens' susceptibility for antimicrobial agents. .	Results of the microbiological analysis of the blood samples collected from patients with clinically suspected infections hospitalized in the ICU during the study period.	After completion of the microbiological analysis, up to 72 hours.
Primary	Isolated pathogens' resistance for antimicrobial agents. .	Results of the microbiological analysis of the blood samples collected from patients with clinically suspected infections hospitalized in the ICU during the study period.	After completion of the microbiological analysis, up to 72 hours.