Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000215

Trial Description

start of 1:1-Block title

Title

Prospective study with the aim to investigate the biological relevance of fibrinolysis products and their use as prognostic and therapeutic biomarkers in SIRS and SEPSIS.

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

Trial Acronym

[---]*

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

The developement of "blood poisonig" or SEPSIS is one of the most important complications in intensive care medicine. The cause of this disease is multifactorial and its treatment prerequisites the use of the whole repertoire of intensive medical care. The soil for sepsis is given by a general inflammation (SIRS) that may affetc all organs. It is difficult to differentiate between the developement of a SIRS and early stages of sepsis. It is known, that patients suffering from SIRS have disorders with their blood coagulation. During coagulation, many by-products occur which are supposed to enhance SIRS. Therefore, this study aims to investigate the biological role and relevance of these products (fibrin fragments). To answer these questions, blood samples from patients will be analyzed, and correlated with liver- kidney- or other organ function parameters.

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

Brief Summary in Scientific Language

Fibrinogen turnover and fibrin degradation are constant processes that result in the production of peptide fragments with biological activity. The concepts that fibrinogen is cleaved into fibrin solely in order to promote clotting, and that the fibrin fragment (FF) byproducts are only markers of activation, are no longer valid. Indeed, these blood-derived signals possess pro- and anti-inflammatory properties and can markedly affect endothelial cell function. FFs represent new players in modulating inter-cell (e.g., leukocyte/endothelial cell) and intra-cell (endothelial signaling) actions. We hypothesize that FFs represent danger signals during conditions such as systemic inflammatory response syndrome (SIRS) and sepsis.

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

Organizational Data

  •   DRKS00000215
  •   2010/08/23
  •   [---]*
  •   yes
  •   Approved
  •   265/09, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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

  •   A41.9 -  Septicaemia, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  • [---]*
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The primary endpoint consists in determining the concentrations of fibrin fragments in patient's blood samples and correlating the levels with the overall survival. The primary endpoint is reached with transfer of the patient from intensive care unit.

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

Secondary Outcome

The secondary endpoint consists in determining the concentrations of fibrin fragments in patient's blood samples and correlating the levels with the progression of disease from SIRS to SEPSIS. The secondary endpoint is reached at progression from SIRS to SEPSIS.

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

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2010/01/01
  •   150
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Stay at ICU >=48h, positive consent, no active neoplasia (>10 years)

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

Exclusion Criteria

active Neoplasia, age <18 years, no consent

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie Klinikum der J.W.-Goethe Universität
    • Mr.  Professor Dr. Dr.  Kai  Zacharowski 
    • Theodor- Stern-Kai 7
    • 60590  Frankfurt am Main
    • 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 scientific-contact
    • Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie Klinikum der J.W.-Goethe Universität
    • Ms.  Dr.  Carla  Jennewein 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • 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
    • Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie Klinikum der J.W.-Goethe Universität
    • Mr.  Dr.  Patrick  Paulus 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • 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
    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • 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.