Trial document




drksid header

  DRKS00005149

Trial Description

start of 1:1-Block title

Title

cytokine elimination as rescue therapy in refractory shock due to sepsis or SIRS

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

In case of septic shock, if stabilisation of circulation is not possible with standard therapy , probability to die is very high. In this situation we apply an additional therapy: a blood purification system is used to remove the inflammatory mediators (cytokines), which are responsible for the circulatory collaps. The blood is treated in the same way as in dialysis, here using a special adsorber (Cytosorb ®) which adsorbs these cytokines. The adsorber is approved for therapy of such cases.
We want to find out, whether circulation in severe shock can be improved by this treatment.

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

Brief Summary in Scientific Language


Progressive shock despite adequate therapy is a deleterious condition. Mortality of refractory septic shock is > 80 %. The main cause for early mortality is circulatory failure and/or failure of cellular energy metabolism (mitochondrial dysfunction) due to excessive cytokine effects.
A correlation between the blood level of cytokines with the severity and mortality of sepsis has been demonstrated repeatedly.

In septic shock the application of extracorporeal blood purification systems is increasingly considered. The elimination of inflammatory mediators is expected to downregulate the excessive systemic inflammatory response and to decrease organ damage.

CytoSorb® (CytoSorbents Corporation, Monmouth Junction, NJ, USA) is an extracorporeal cytokine adsorber with a CE-Mark regulatory approval (0344CE) , which is indicated for use in cases of elevated cytokines. The adsorber consists of a biocompatible polymer with high capacity of adsorption, preferential for molecules in the range of ~10-50 kDa. Thus, interleukin 6 (IL6), TNF alpha, IL10, IL1 or IL8 are eliminated from the circulation.

There are limited data up to now: a significant reduction of cytokines has primarily been shown in brain dead organ donors, subsequently in a pilot study in septic shock patients.
Animal experiments demonstrated improved organ functions, increased blood pressure, and better survival in a model of letal endotoxemia.
Aim of this study is to evaluate the effect of cytokin removal with an extracorporeal adsorber (CytoSorb ®) in case of refractory shock due to sepsis or SIRS.

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

Organizational Data

  •   DRKS00005149
  •   2013/07/17
  •   [---]*
  •   no
  •   Approved
  •   BB 048/13, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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

  •   R57.2 -  Septic shock
  •   R65.9 -  Systemic Inflammatory Response Syndrome, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Cytokine elimination is used in every case of refractory septic shock as rescue therapy. Therefore we have only one arm. In this study we collect the data of these cases.
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
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Change of norepinephrine dose 6 and 12 h after start of Cytosorb(R) compared to the dose at the timepoint of start.

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

Secondary Outcome

Organfunctions (SOFA-score), clearance of lactate, vasopressor dependency index

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 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/08/17
  •   20
  •   Monocenter 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

Sepsis or SIRS with refractory shock after 4-6 h guideline-based early goal directed therapy

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

Exclusion Criteria

- age < 18 years
- IL 6 < 1000 pg/ml
- infection with methicillin-resistant staphylococci
- infection with vancomycin-resistant enterococci
- maximal therapy not indicated (e.g.: limited prognosis due to chronical illness)

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • CytoSorbents
    • Mr.  Dr.  Christian  Steiner 
    • Bölschestr. 116
    • 12587  Berlin
    • 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
    • Universitätsmedizn Greifswald
    • Ms.  Dr.  Sigrun  Friesecke 
    • Ferdinand-Sauerbruchstr. 1
    • 17475  Greifswald
    • 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
    • Universitätsmedizn Greifswald
    • Ms.  Dr.  Sigrun  Friesecke 
    • Ferdinand-Sauerbruchstr. 1
    • 17475  Greifswald
    • 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
    • CytoSorbents
    • Mr.  Dr.  Christian  Steiner 
    • Bölschestr. 116
    • 12587  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 complete, follow-up complete
  •   2015/12/31
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.