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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01388686
First received: July 5, 2011
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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
Bacteremia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Analysis of Proven Bacteremia, CVC-associated Infections and Sepsis

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Total number of blood cultures drawn and total number of positive findings in ICUs [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Prevalence on CVC - associated sepsis/CLABSIs [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
INABBRA
Participating hospitals in the INABBRA alliance.

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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388686

Contacts
Contact: Claudia Spies, MD, Prof. +49 30 450 551001 claudia.spies@charite.de

Locations
Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin Recruiting
Berlin, Germany, 13353
Contact: Claudia Spies, MD, Prof.    +49 30 450 551001    claudia.spies@charite.de   
Sub-Investigator: Maria Deja, MD , PD         
Sub-Investigator: Irit Nachtigall, MD, Dr.         
Sub-Investigator: Andreas Rothbart, MD, Dr.         
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

Additional 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
Study First Received: July 5, 2011
Last Updated: May 23, 2014
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on July 23, 2014