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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Timo Sturm, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier:
NCT01530932
First received: November 9, 2011
Last updated: October 20, 2014
Last verified: October 2014
  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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530932

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

No publications provided

Responsible Party: Timo Sturm, Principal Investigator, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT01530932     History of Changes
Other Study ID Numbers: 2011-411M-MA
Study First Received: November 9, 2011
Last Updated: October 20, 2014
Health Authority: Germany: Ethics Comission

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

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on November 19, 2014