- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01530932
Immune Activation, Hypoxia and Vasoreaction in Sepsis of Pulmonary Versus Abdominal Origin
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Mannheim, Germany, 68167
- University Hospital Mannheim
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Sturm T, Leiblein J, Clauss C, Erles E, Thiel M. Bedside determination of microcirculatory oxygen delivery and uptake: a prospective observational clinical study for proof of principle. Sci Rep. 2021 Dec 31;11(1):24516. doi: 10.1038/s41598-021-03922-4.
- Sturm T, Leiblein J, Schneider-Lindner V, Kirschning T, Thiel M. Association of Microcirculation, Macrocirculation, and Severity of Illness in Septic Shock: A Prospective Observational Study to Identify Microcirculatory Targets Potentially Suitable for Guidance of Hemodynamic Therapy. J Intensive Care Med. 2018 Apr;33(4):256-266. doi: 10.1177/0885066616671689. Epub 2016 Sep 29.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-411M-MA
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