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

NCT ID: NCT01530932

Last Updated: 2014-10-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-04-30

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.

Conditions

Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitätsmedizin Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Timo Sturm

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Mannheim

Mannheim, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 34972827 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27686326 (View on PubMed)

Other Identifiers

2011-411M-MA

Identifier Type: -

Identifier Source: org_study_id