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

NCT01530932 | Completed DMC

• 1 other identifier: 2011-411M-MA
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

sepsis; tissue oxygenation; tissue perfusion; immune reaction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• sepsis (according to the criteria of the International Sepsis Definition Conference)

You may not qualify if:

• pregnancy
• malignancy
• corticoid therapy
• organ transplantation
• renal insufficiency with HD

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Study Sites (1)

University Hospital Mannheim

Mannheim, 68167, Germany

Location

Related Publications (2)

• 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.

  PMID: 34972827 DERIVED

• 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.

  PMID: 27686326 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: February 10, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 21, 2014

Record last verified: 2014-10

Locations

DE (1)