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Bedside vs. Standard Microbiological Blood Culture Diagnostics - BEMIDIA Study (BEMIDIA)

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ClinicalTrials.gov Identifier: NCT03000049
Recruitment Status : Unknown
Verified December 2016 by Sven-Olaf Kuhn, University Medicine Greifswald.
Recruitment status was:  Recruiting
First Posted : December 21, 2016
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Sven-Olaf Kuhn, University Medicine Greifswald

Brief Summary:

With a completely bedside blood culture diagnostics system (BACTEC blood culture system in combination with the Accelerate ID/AST System) it is possible to optimize the initial antimicrobial therapy in patients with sepsis and septic shock.

Prospective observational, open-label mono-center study to compare a completely bedside blood culture diagnostics system (BACTEC blood culture system in combination with the Accelerate ID/AST System and Curetis Univero System) with standard blood culture diagnostics in patients with sepsis or septic shock.


Condition or disease Intervention/treatment
Sepsis Septic Shock Other: bedside blood culture

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bedside vs. Standard Microbiological Blood Culture Diagnostics - BEMIDIA Study
Study Start Date : November 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock




Primary Outcome Measures :
  1. Time to a significant change of antimicrobial therapy from the time of the diagnosis of sepsis or septic shock [ Time Frame: Nov. 2016 - Nov. 2017 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with sepsis or septic shock with planned blood culture drawing
Criteria

Inclusion Criteria:

  • Patients with a new diagnosed sepsis or septic shock: emergency department, operating theatre, intensive care unit and planed blood culture diagnostics.
  • informed written consent

Exclusion Criteria:

  • Pediatric patients (< 18 Years)
  • DNR-order

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): NCT03000049


Contacts
Contact: Matthias Gründling, MD gruendli@uni-greifswald.de

Locations
Germany
Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany Recruiting
Greifswald, Germany, 17475
Contact: Sven-Olaf Kuhn, MD    3834507952    kuhn@uni-greifswald.de   
Contact: Matthias Gründling, MD         
Principal Investigator: Matthias Gründling, MD         
Sponsors and Collaborators
University Medicine Greifswald

Responsible Party: Sven-Olaf Kuhn, Sven-Olaf Kuhn MD, University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT03000049     History of Changes
Other Study ID Numbers: SD_BK_1_ANI
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sven-Olaf Kuhn, University Medicine Greifswald:
sepsis
septic shock
blood cultures
anti-infective therapy

Additional relevant MeSH terms:
Sepsis
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock