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Immune Activation, Hypoxia and Vasoreaction in Sepsis of Pulmonary Versus Abdominal Origin

Sponsor
Universitätsmedizin Mannheim (Other)
Overall Status
Completed
CT.gov ID
NCT01530932
Collaborator
(none)
20
Enrollment
1
Location
26
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sepsis remains a common entity in critical care patients with remarkable mortality. Pulmonary and abdominal infections (with subsequent sepsis) are the most common in the ICU. Despite extended research activities, no differences in patient outcome or organ dysfunction were revealed.

Sepsis is a complex immune reaction phenomenon based on unbalanced activation and suppression. In addition to changes of cytokine levels and immune cell activity, underlying genetic reactions are present. For instance, expression of miRNA (as a potential important step of immune cell activation) is likely changed during systemic and local immune reactions.

The aim of this study is to perform a detailed assay of immune cell activation, to investigate the levels of pro- and antiinflammatory cytokines and the various expression of miRNA depending on the origin of infection in the two most common sides. This means in ICU patients with early pulmonary or abdominal sepsis as well as in healthy controls. Additionally, clinical parameters of organ function, current infection markers as CRP and procalcitonin, cardiovascular function and heart rate variability will be assessed. Parameters of local tissue perfusion in a dynamic testing during forearm ischemia and plasma adenosine concentration will be measured.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Immune Activation, Hypoxia and Vasoreaction in Sepsis of Pulmonary Versus Abdominal Origin
    Study Start Date :
    Feb 1, 2012
    Actual Primary Completion Date :
    Apr 1, 2014
    Actual Study Completion Date :
    Apr 1, 2014

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      • sepsis (according to the criteria of the International Sepsis Definition Conference)
      Exclusion Criteria:

      • pregnancy

      • malignancy

      • corticoid therapy

      • organ transplantation

      • renal insufficiency with HD

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University Hospital Mannheim Mannheim Germany 68167

      Sponsors and Collaborators

      • Universitätsmedizin Mannheim

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Timo Sturm, Principal Investigator, Universitätsmedizin Mannheim
      ClinicalTrials.gov Identifier:
      NCT01530932
      Other Study ID Numbers:
      • 2011-411M-MA
      First Posted:
      Feb 10, 2012
      Last Update Posted:
      Oct 21, 2014
      Last Verified:
      Oct 1, 2014
      Keywords provided by Timo Sturm, Principal Investigator, Universitätsmedizin Mannheim
      sepsis
      tissue oxygenation
      tissue perfusion
      immune reaction
      Additional relevant MeSH terms:
      Sepsis
      Toxemia
      Hypoxia

      Study Results

      No Results Posted as of Oct 21, 2014