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

• ClinicalTrials.gov Identifier: NCT01530932
• Recruitment Status: Completed
• First Posted: February 10, 2012
• Last Update Posted: October 21, 2014
• Sponsor: Universitätsmedizin Mannheim
• Information provided by (Responsible Party): Timo Sturm, Universitätsmedizin Mannheim

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
Sepsis

Study Design

• Study Type: Observational
• Estimated 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: February 2012
• Actual Primary Completion Date: April 2014
• Actual Study Completion Date: April 2014

Groups and Cohorts

Outcome Measures

Biospecimen Retention:   Samples With DNA

Blood samples

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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):

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.

• Responsible Party: Timo Sturm, Principal Investigator, Universitätsmedizin Mannheim
• ClinicalTrials.gov Identifier: NCT01530932
• Other Study ID Numbers: 2011-411M-MA
• 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