We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01388686
Recruitment Status : Terminated
First Posted : July 7, 2011
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Bacteremia

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.

Study Design

Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Analysis of Proven Bacteremia, CVC-associated Infections and Sepsis
Study Start Date : August 2009
Primary Completion Date : December 2010
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
INABBRA
Participating intensive care units of hospitals in the INABBRA alliance.


Outcome Measures

Primary Outcome Measures :
  1. Total number of blood cultures drawn and total number of positive findings in ICUs [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Prevalence on CVC - associated sepsis/CLABSIs [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Hospitals without intensive care unit.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388686


Locations
Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Director: Claudia Spies, MD, Prof. Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
More Information

Publications:

Responsible Party: Claudia Spies, Prof. MD, Director of the Dept. of Anaesthesiology and Intensive Care Medicine, CVK, CCM, Charite University, Berlin, Germany, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01388686     History of Changes
Other Study ID Numbers: BAC_BLOOD
First Posted: July 7, 2011    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016

Keywords provided by Claudia Spies, Charite University, Berlin, Germany:
sepsis
catheter
blood stream infection
blood culture

Additional relevant MeSH terms:
Sepsis
Bacteremia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Bacterial Infections