Trial document




drksid header

  DRKS00011188

Trial Description

start of 1:1-Block title

Title

Early Detection of LIFE-threatening Infections – Rapid Diagnosis by a multivalent innovative Biomarkerpanel on a mobile Point-of Care (POC) device Biomarker for Early Sepsis Diagnosis "BEdSide"

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

LIFE-POC-BEdSide

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The aim of this project is the reduction of mortality and morbidity of critically ill patients with infectious inflammation by the combined use of biomarkers for risk assessment, early diagnosis and therapy evaluation using a new mobile multiplex point-of-care (POC) device.
This cohort study is designed to investigate the clinical utility of an innovative biomarker panel for the early identification of patients with sepsis in acute settings. Early blood samples of patients with suspected sepsis will be obtained and a prototype mobile point-of-care (POC)-device for eligible biomarkers will be developed. In the central emergency departments of the University Hospital Jena and the Charité Universitätsmedizin Berlin, blood samples from a total of 1500 patients will collected and analyzed. In addition the biomarker panel will be tested retrospectively in blood samples from septical patients included into the HYPRESS-Study.
Measured biomarkers will be evaluated with respect to their utility in early diagnosis, risk stratification and therapy management and a biomarker panel with high clinical relevance will be determined.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011188
  •   2016/10/20
  •   [---]*
  •   yes
  •   Approved
  •   4912-08/16, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   A41 -  Other sepsis
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   This cohort study is designed to investigate the clinical utility of an innovative biomarker panel for the early identification of patients with sepsis in acute settings. Early blood samples of patients with suspected sepsis will be obtained and a prototype mobile point-of-care (POC)-device for eligible biomarkers will be developed. In the central emergency departments of the University Hospital Jena and the Charité Universitätsmedizin Berlin, blood samples from a total of 1500 patients will collected and analyzed. In addition the biomarker panel will be tested retrospectively in blood samples from septical patients included into the HYPRESS-Study.
    Measured biomarkers will be evaluated with respect to their utility in early diagnosis, risk stratification and therapy management and a biomarker panel with high clinical relevance will be determined.
    In the emergency room and in case of further laying, blood samples are taken, documentation of the relocation / discharge diagnoses.
    Follow-up of the patient during the stay (96h):
    documentation of the following parameters: sepsis / septic shock according to the current definition considering the SOFA score as well as the definition according to ACCP / SCCM consensus conference, organ dysfunction, organ replacement procedure, laboratory parameters concerning infection and organ dysfunction, infection focus, microbiology results, outpatient care, relocation from normal station, intensive care unit (ITS), intermediate care station (IMC), and hospital-, intensive care unit / intermediate care unit length of stay, status at discharge.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Occurrence of sepsis within 96 hours

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Septic shock within 96h, hospital / 28 day mortality, infection focus, microbiological examination results, organdysfunction, organs replacement, clinical and laboratory findings and medication during inpatient stay, transfer to ITS, ITS days, KH days, maximum SOFA score

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/12/19
  •   1500
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Glasgow Coma Scale <15, respiratory rate ≥ 22 / min, systolic blood pressure ≤ 100 mmHg

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Known pregnancy, acute myocardial infarction, leading traumadiagnosis, patients with therapy with limited life expectancy <28 days, already participants of the study with pre-stay

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Jena
    • 07747  Jena
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Charité - Universitätsmedizin Berlin Bereich Notfallmedizin/Rettungsstellen
    • Mr.  Prof. Dr. med.  Martin  Möckel 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Adrenomed AG
    • Ms.  Dr.  Frauke  Hein 
    • Neuendorfstr. 15a
    • 16761  Henningsdorf
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Sphingotec GmbH
    • Mr.  Dr.  Andreas  Bergmann 
    • Neueundorfstr. 15a
    • 16761  Henningsdorf
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Thermo Fisher Scientific Biomarkers – BRAHMS GmbH
    • Mr.  Dr.  Volker  Liebenberg 
    • Neuendorfstraße 24
    • 16761  Henningsdorf
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Alere Technologies GmbH
    • Mr.  Dr.  Tobias  Muenz 
    • Loebstedter Straße 103-105
    • 07749  Jena
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum JenaKlinik für Anaesthesiologie und Intensivmedizin
    • Mr.  PD Dr. med.  Johannes  Winning 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum JenaKlinik für Anaesthesiologie und Intensivmedizin
    • Mr.  PD Dr. med.  Johannes  Winning 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Bildung und Forschung
    • Kapelle-Ufer 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.