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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01530932
First Posted: February 10, 2012
Last Update Posted: October 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Timo Sturm, Universitätsmedizin Mannheim
  Purpose

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
Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Activation, Hypoxia and Vasoreaction in Sepsis of Pulmonary Versus Abdominal Origin

Resource links provided by NLM:


Further study details as provided by Timo Sturm, Universitätsmedizin Mannheim:

Biospecimen Retention:   Samples With DNA
Blood samples

Estimated Enrollment: 20
Study Start Date: February 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with sepsis of pulmonary or abdominal origin with admission to the ICU in the first 48 hours of sepsis onset
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530932


Locations
Germany
University Hospital Mannheim
Mannheim, Germany, 68167
Sponsors and Collaborators
Universitätsmedizin Mannheim
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Timo Sturm, Principal Investigator, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT01530932     History of Changes
Other Study ID Numbers: 2011-411M-MA
First Submitted: November 9, 2011
First Posted: February 10, 2012
Last Update Posted: October 21, 2014
Last Verified: October 2014

Keywords provided by Timo Sturm, Universitätsmedizin Mannheim:
sepsis
tissue oxygenation
tissue perfusion
immune reaction

Additional relevant MeSH terms:
Sepsis
Toxemia
Hypoxia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms