Trial document




drksid header

  DRKS00003392

Trial Description

start of 1:1-Block title

Title

Predictors of Sepsis - Pred Sep

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

Trial Acronym

PRED-SEP

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

Infection is one of the most important complications after acute stroke. There is no early marker to distinguish patients who will develop systemic infection. In clinical routine, it would be very helpful to identify those patients who will benefit from early antibiotic therapy. Better understanding of the relationship between autonomic control and immune response after stroke would provide novel options for an individually optimized antibiotic, beta-blocker and cholinergic therapy.
The present study will explore whether indices of heart rate rhythms that reflect particular aspects of autonomous nervous system (ANS) activity predict the development of infections and severe sepsis after acute ischemic stroke.
Additional correlation analysis between heart rate variability (HRV) indices and pro- and anti-inflammatory markers will show to which extent HRV indices of ANS activity are associated with the inflammation process.

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

Brief Summary in Scientific Language

Infection is one of the most important complications after acute stroke. This is substantially based on a stroke-induced immunsuppression, which is mediated by the autonomous nervous system (ANS) besides other mechanisms. Its activity can be determined from parameters of the heart rate variability (HRV). In animal experimental studies about stroke-induced immunsuppression could be proven the connection between infection rates and the role of the ANS. In different clinical studies the predictive value of HRV parameters regarding developing infections and/or sepsis under the condition of different underlying diseases in patients without stroke could be proven.
In the study PRED-SEP the predictive value of HRV parameters for the development of infections is examined in patients after acute ischemic stroke for the first time.

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

Organizational Data

  •   DRKS00003392
  •   2012/02/14
  •   [---]*
  •   yes
  •   Approved
  •   3192-07/11, 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

  •   I63.5 -  Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries
  •   A41 -  Other septicaemia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with acute ischemic stroke are treated according to clinical practice. Additionally a long-time-ECG and blood-analyses are done.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

Development of infection within the subacute phase (day 1-5) of the stroke.
Infection is defined according to the PANTHERIS study:
- Pneumonia is defined as presence of at least one of the A and one of the B criteria: A) abnormal respiratory examination, pulmonary infiltrates in chest X-Ray; B) productive cough with purulent sputum, microbiological cultures from lower respiratory tract or blood cultures, leukocytosis, and elevation of C-reactive protein (CRP).
- Urinary tract infection is defined as the presence of two of the following criteria: fever (>38.0 °C), urine sample positive for nitrite, leucocyturia, and significant bacteriuria.
- Infection is also diagnosed if temperature is above 38.0°C on at least 2 determinations with additional leucocytosis and positive blood cultures, but no determined focus.

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

Secondary Outcome

Development of SIRS and severe sepsis in the subacute phase (day 1-5) after Stroke and functional outcome after 3 months.
-SIRS (criteria I) is defined according to Guidelines of the German Sepsis Society
-Severe Sepsis (criteria I, II and III) is defined according to Guidelines of the German Sepsis Society.
- Functional outcome is measured by lethality and neurological scores (modified Rankin Scale, Barthel Index, NIHSS).

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
  •   2012/02/25
  •   240
  •   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

Ischemic infarction in the territory of the middle cerebral artery.
Age ≥ 18.
NIH stroke score NIHSS > 8.

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

Exclusion Criteria

Existing infections at admission.
History of previous strokes.
Cardiogenic arrhythmias.

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Neurologie
    • Mr.  Dr. med.  Dirk  Brämer 
    • Erlanger Allee 101
    • 07740  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 scientific-contact
    • Klinik für Neurologie, Universitätsklinikum Jena
    • Mr.  Prof. Dr. med.  Dirk  Hoyer 
    • Erlanger Allee 101
    • 07740  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
    • Klinik für Neurologie
    • Mr.  Dr. med.  Dirk  Brämer 
    • Erlanger Allee 101
    • 07740  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
    • Hannoversche Straße 28-30
    • 10115  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
  •   2015/01/31
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.