Prevalence of CVC-associated Sepsis and Use of Blood Cultures in Berlin - Brandenburg

Bacteremia Clinical Trial

Official title:

Retrospective Analysis of Proven Bacteremia, CVC-associated Infections and Sepsis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01388686
• Other study ID #: BAC_BLOOD
• Status: Terminated
• Phase: N/A
• First received: July 5, 2011
• Last updated: November 22, 2016
• Start date: August 2009
• Est. completion date: November 2015

Study information

• Verified date: November 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: November 2015
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Intensive care units of hospitals in the INABBRA alliance.

• Patients with bacteremia.

Exclusion Criteria:

• Hospitals without intensive care unit.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bacteremia
• Sepsis

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Brun-Buisson C, Doyon F, Carlet J, Dellamonica P, Gouin F, Lepoutre A, Mercier JC, Offenstadt G, Régnier 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. — View 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. — View 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. — View 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. Erratum in: Clin Infect Dis. 2010 Apr 1;50(7):1079. Dosage error in article text. Clin Infect Dis. 2010 Feb 1;50(3):457. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of blood cultures drawn and total number of positive findings in ICUs	Retrospective analysis of cases with positive bloodculture among patients in ICU setting compared to the total amount of blood cultures taken in the same period of time and same hospital.	1 year	No
Secondary	Prevalence on CVC - associated sepsis/CLABSIs		1 year	No

External Links

•   Homepage of the INABBRA alliance with its description.