NCT01388686

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2011

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

July 5, 2011

Last Update Submit

November 22, 2016

Conditions

Bacteremia

Keywords

sepsiscatheterblood stream infectionblood culture

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Prevalence on CVC - associated sepsis/CLABSIs

    1 year

Study Arms (1)

INABBRA

Participating intensive care units of hospitals in the INABBRA alliance.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with bacteremia on intensive care units of different primary and secondary care hospitals in the region of Berlin-Brandenburg.

You may qualify if:

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

You may not qualify if:

  • Hospitals without intensive care unit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (5)

  • 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.

    PMID: 8810595BACKGROUND

  • 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.

    PMID: 19246122BACKGROUND

  • 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.

    PMID: 7674528BACKGROUND

  • 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.

    PMID: 18478503BACKGROUND

  • 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.

    PMID: 19489710BACKGROUND

MeSH Terms

Conditions

BacteremiaSepsis

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Claudia Spies, MD, Prof.

    Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. MD, Director of the Dept. of Anaesthesiology and Intensive Care Medicine, CVK, CCM, Charite University, Berlin, Germany

Study Record Dates

First Submitted

July 5, 2011

First Posted

July 7, 2011

Study Start

August 1, 2009

Primary Completion

December 1, 2010

Study Completion

November 1, 2015

Last Updated

November 23, 2016

Record last verified: 2016-11

Locations

DE(1)