Clinical trial NCT01388686: Prevalence of CVC-associated Sepsis and Use of Blood Cultures in Berlin - Brandenburg
Official title: Retrospective Analysis of Proven Bacteremia, CVC-associated Infections and Sepsis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bacteremia
Keywords: sepsis
catheter
blood stream infection
blood culture
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-07-07
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bacteremia on intensive care units of different primary and secondary care hospitals in the region of Berlin-Brandenburg.

Brief summary: Structured web-based survey in selected hospitals with intensive care units in Berlin- Brandenburg to collect data on the overall number of blood cultures (used) and the prevalence of (positive blood cultures in patients with) CVC - associated sepsis.

Detailed description: The use of CVC represents one of the major risk factors for sepsis, a highly prevalent disease in ICUs. Blood cultures obtained prior to antibiotic administration are part of the SSC Resuscitation Bundle and essential for the outcome of the patient. The CDC criteria to diagnose sepsis do not take into account the overall number of blood cultures obtained and thus, lead to an underestimation of the true incidence of sepsis. Up to now, few data is available on the total number of blood cultures obtained and the relation to the incidence of sepsis in German ICUs.

Eligibility criteria: Inclusion Criteria:

* Intensive care units of hospitals in the INABBRA alliance.
* Patients with bacteremia.

Exclusion Criteria:

* Hospitals without intensive care unit.

Primary outcomes:
measure: Total number of blood cultures drawn and total number of positive findings in ICUs
timeFrame: 1 year
Secondary outcomes:
measure: Prevalence on CVC - associated sepsis/CLABSIs
timeFrame: 1 year
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
citation: Brun-Buisson C, Doyon F, Carlet J. Bacteremia and severe sepsis in adults: a multicenter prospective survey in ICUs and wards of 24 hospitals. French Bacteremia-Sepsis Study Group. Am J Respir Crit Care Med. 1996 Sep;154(3 Pt 1):617-24. doi: 10.1164/ajrccm.154.3.8810595.
citation: Tacconelli E, Smith G, Hieke K, Lafuma A, Bastide P. Epidemiology, medical outcomes and costs of catheter-related bloodstream infections in intensive care units of four European countries: literature- and registry-based estimates. J Hosp Infect. 2009 Jun;72(2):97-103. doi: 10.1016/j.jhin.2008.12.012. Epub 2009 Feb 25.
citation: Brun-Buisson C, Doyon F, Carlet J, Dellamonica P, Gouin F, Lepoutre A, Mercier JC, Offenstadt G, Regnier B. Incidence, risk factors, and outcome of severe sepsis and septic shock in adults. A multicenter prospective study in intensive care units. French ICU Group for Severe Sepsis. JAMA. 1995 Sep 27;274(12):968-74.
citation: Gastmeier P, Geffers C. [Nosocomial infections in Germany. What are the numbers, based on the estimates for 2006?]. Dtsch Med Wochenschr. 2008 May;133(21):1111-5. doi: 10.1055/s-2008-1077224. German.
citation: Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376.