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Monocyte Profiles in Critically Ill Patients With Pseudomonas Aeruginosa Sepsis (MIPSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03044223
Recruitment Status : Unknown
Verified February 2017 by Manfred Weiss, University of Ulm.
Recruitment status was:  Recruiting
First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Information provided by (Responsible Party):
Manfred Weiss, University of Ulm

Brief Summary:
The present study focuses on patients with Pseudomonas aeruginosa (PSA) sepsis. The aim of the present study is to find out whether the M1 (pro-inflammatory) or M2 (anti-inflammatory) phenotype predominates in blood monocytes in critically ill patients with PSA-sepsis, and whether the severity of sepsis and outcome is associated with distinct monocyte phenotype and function.

Condition or disease
Pseudomonas Infections Pseudomonas Septicemia Pseudomonas; Pneumonia Pseudomonal Bacteraemia Pseudomonas Urinary Tract Infection Pseudomonas Gastrointestinal Tract Infection Sepsis Sepsis, Severe Critically Ill

Detailed Description:

During bacterial related sepsis, one of the key playing cells are macrophages, monocytes and T-lymphocytes (Hotchkiss et al., 2003). Macrophages and monocytes are supposed to be essential for the septic reaction to Gram-negative bacteria (Hotchkiss et al. 2003). Generally, there are two dominant types of macrophages: the pro-inflammatory M1 macrophage and the anti-inflammatory M2 macrophage (Mantovani et al., 2006). Similar to this macrophage characteristics, monocytes can also be categorized into pro-or anti-inflammatory. These macrophage/monocyte phenotypes can be differentiated in vitro from freshly isolated human blood monocytes using either GM-CSF giving raise to M1 macrophage/monocyte or M-CSF resulting in M2 macrophage/monocyte (Mantovani et al., 2006; Neu et al., 2013). Brunialti et al. (2012) have already demonstrated that the population of antiinflammatory M2 monocytes in septic patients is bigger than the pro-inflammatory M1 population. However, the authors did not further analyze the underlying mechanisms of M2 polarization nor did they identify the sepsis-causing pathogens.

In the present study, monocytes and macrophages of patients with Pseudomonas aeruginosa (PSA) sepsis are characterized by their surface marker expression profile via flow cytometry and cytokine pattern by ELISA in vivo and after ex-vivo LPS stimulation. In addition, an ex-vivo model system for PSA induced sepsis is validated. Blood of critically ill patients in the ICU infected with PSA is sampled to isolate peripheral blood mononuclear cells (PBMCs). Blood monocytes are analyzed for surface marker expression to determine the relative proportions of M1 and M2 monocytes in these patients and in healthy controls by flow cytometry

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phenotypical Und Functional Characterization of Macrophages in Critically Ill Patients With Pseudomonas Aeruginosa Induced Sepsis
Study Start Date : August 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Primary Outcome Measures :
  1. Monocyte surface marker expression in critically ill patients with Pseudomonas aeruginosa sepsis [ Time Frame: two years ]
    Monocyte type 1, type 2 surface marker expression

Secondary Outcome Measures :
  1. Cytokine concentrations in serum and production after ex-vivo stimulation of isolated monocytes of critically ill patients with Pseudomonas aeruginosa sepsis with LPS [ Time Frame: four years ]
    IL-8 and IFN-gamma

Biospecimen Retention:   Samples Without DNA
blood, plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients with sepsis with microbiologically proven infection with Pseudomonas aeruginosa

Inclusion Criteria:

  • age > 18 years
  • critically ill patients with sepsis
  • microbiologically proven infection with Pseudomonas aeruginosa

Exclusion Criteria:

  • life expectancy < 24 hours
  • participation in other studies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03044223

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Contact: Manfred Weiss, MD, MBA +49 731 500 60226
Contact: Eberhard Barth, MD +49 731 500 60050

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Clinic of Anesthesiology Recruiting
Ulm, Germany, 89070
Contact: Manfred Weiss, MD, MBA    +49-(0)731-500-60226   
Contact: Eberhard Barth, MD    +49-(0)731-500-60050   
Sub-Investigator: Eberhard Barth, MD         
Sub-Investigator: Michael Goergieff, MD         
Sub-Investigator: Hendrik Bracht, MD         
Sub-Investigator: Florian Gebhard, MD         
Sub-Investigator: Doris Henne-Bruns, MD         
Sub-Investigator: Marc-Eric Halatsch, MD         
Sub-Investigator: Karl-Heinz Orend, MD         
Sub-Investigator: Andreas Essig, MD         
Sub-Investigator: Christian Riedel, PhD         
Principal Investigator: Anne Sedlag, Biochemist         
Sponsors and Collaborators
University of Ulm
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Principal Investigator: Manfred Weiss, MD, MBA University Ulm, University Hospital Ulm
Principal Investigator: Anne Sedlag, Biochemist University Ulm, Institute of Microbiology and Biotechnology

Publications of Results:
Other Publications:
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Responsible Party: Manfred Weiss, Professor, MD, University of Ulm Identifier: NCT03044223    
Other Study ID Numbers: PSA_Sepsis_M_1_2
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Manfred Weiss, University of Ulm:
pseudomonas aeruginosa
critically ill patient
severity of disease
Additional relevant MeSH terms:
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Communicable Diseases
Urinary Tract Infections
Pseudomonas Infections
Critical Illness
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Disease Attributes
Urologic Diseases
Bacterial Infections
Gram-Negative Bacterial Infections