Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009684

Trial Description

start of 1:1-Block title

Title

Incidence and extent of a systemic inflammatory response in patients after successful cardiopulmonary resuscitation

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

Despite modern intensive care, prognosis of patients suffering cardiac arrest still remains poor. This high mortality can be attributed to the development of the post-cardiac arrest syndrome, which is thought to be mediated by a systemic inflammatory response. In this prospective observational study the incidence and extent of a systemic inflammatory response will be investigated in blood samples from patients after successful cardiopulmonary resuscitation which will be compared to a control group with coronary artery disease without acute myocardial infarction.

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

Brief Summary in Scientific Language

Despite improvement in modern intensive care, patients after primarily successful resuscitation still have an impaired prognosis. Intrahospital mortality can be attributed to the development of the post-cardiac arrest syndrome, a unique and complex combination of pathophysiological processes which include anoxic brain injury, myocardial dysfunction, systemic ischemia-reperfusion response and the unresolved pathological condition that caused circulatory arrest [2]. It is thought that whole body ischemia and finally the return of spontaneous circulation after successful cardiopulmonary resuscitation results in generation of reactive oxygen species [3] which lead to induction of a systemic inflammatory response [4] with production of proinflammatory cytokines [5] as well as an endothelial damage with microthrombosis [6, 7]. These processes contribute to microcirculatory disorder and capillary leakage, which finally lead to a “sepsis-like” syndrome [5]. In this prospective observational study the incidence and extent of a systemic inflammatory response will be investigated in blood samples from patients after circulatory arrest, which will be compared to a control group with coronary artery disease without acute myocardial infarction.

1. Peberdy MA, Kaye W, Ornato JP, Larkin GL, Nadkarni V, Mancini ME et al. Cardiopulmonary resuscitation of adults in the hospital: a report of 14720 cardiac arrests from the National Registry of Cardiopulmonary Resuscitation. Resuscitation. 2003;58(3):297-308.
2. Neumar RW, Nolan JP, Adrie C, Aibiki M, Berg RA, Bottiger BW et al. Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication. A consensus statement from the International Liaison Committee on Resuscitation (American Heart Association, Australian and New Zealand Council on Resuscitation, European Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Asia, and the Resuscitation Council of Southern Africa); the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiopulmonary, Perioperative, and Critical Care; the Council on Clinical Cardiology; and the Stroke Council. Circulation. 2008;118(23):2452-83.
3. Idris AH, Roberts LJ, 2nd, Caruso L, Showstark M, Layon AJ, Becker LB et al. Oxidant injury occurs rapidly after cardiac arrest, cardiopulmonary resuscitation, and reperfusion. Crit Care Med. 2005;33(9):2043-8.
4. Gando S, Nanzaki S, Morimoto Y, Kobayashi S, Kemmotsu O. Out-of-hospital cardiac arrest increases soluble vascular endothelial adhesion molecules and neutrophil elastase associated with endothelial injury. Intensive care medicine. 2000;26(1):38-44.
5. Adrie C, Adib-Conquy M, Laurent I, Monchi M, Vinsonneau C, Fitting C et al. Successful cardiopulmonary resuscitation after cardiac arrest as a "sepsis-like" syndrome. Circulation. 2002;106(5):562-8.
6. Gando S, Nanzaki S, Morimoto Y, Kobayashi S, Kemmotsu O. Alterations of soluble L- and P-selectins during cardiac arrest and CPR. Intensive care medicine. 1999;25(6):588-93.
7. Gando S, Kameue T, Nanzaki S, Nakanishi Y. Massive fibrin formation with consecutive impairment of fibrinolysis in patients with out-of-hospital cardiac arrest. Thromb Haemost. 1997;77(2):278-82.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009684
  •   2015/11/27
  •   [---]*
  •   yes
  •   Approved
  •   328/09, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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

  •   I46.0 -  Cardiac arrest with successful resuscitation
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Blood samples from patients after cardiac arrest with successful resuscitation
  •   Blood samples from patients with coronary artery disease without acute myocardial infarction
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

Quantitative analysis of peripheral blood leucocyte subclasses; Expression of markers of antigen presentation; Leucocyte response to activation by stimulatory agents; Leucocyte and whole blood expression of markers of innate immunity inflammatory signaling, including toll-like receptor and inflammasome signaling; Single blood sample from control group; Sequential blood sampling in patients in the first hours after survived cardiac arrest as well as 1 day and 2 days after resuscitation;

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

Secondary Outcome

/

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
  •   2010/09/21
  •   100
  •   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

Cardiac arrest with successful resuscitation; Coronary artery disease without acute myocardial infarction

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

Exclusion Criteria

Preexisting acute- or chronic-inflammatory diseases; Preexisting acute- or chronic-infectious diseases; Multiple organ dysfunction syndrome; Immunosuppressive medication

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg / Universitäts-Herzzentrum Freiburg - Bad Krozingen
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   004976127034010
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Freiburg / Universitäts-Herzzentrum Freiburg - Bad Krozingen
    • Ms.  Dr.  Katrin  Fink 
    • Hugstetter Str. 55
    • 79106  Freiburg im Breisgau
    • 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 Freiburg / Universitäts-Herzzentrum Freiburg - Bad Krozingen
    • Ms.  Dr.  Katrin  Fink 
    • Hugstetter Str. 55
    • 79106  Freiburg im Breisgau
    • 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
    • Universitätsklinikum Freiburg / Universitäts-Herzzentrum Freiburg - Bad Krozingen
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   004976127034010
    •   [---]*
    •   [---]*
    •   [---]*
    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.