Monocyte Profiles in Critically Ill Patients With Pseudomonas Aeruginosa Sepsis

NCT03044223 | Recruiting

• 1 other identifier: PSA_Sepsis_M_1_2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pseudomonas aeruginosa; critically ill patient; sepsis; monocyte; macrophage; cytokine; severity of disease

Outcome Measures

Primary Outcomes (1)

• Monocyte surface marker expression in critically ill patients with Pseudomonas aeruginosa sepsis

  Monocyte type 1, type 2 surface marker expression

  two years

Secondary Outcomes (1)

• Cytokine concentrations in serum and production after ex-vivo stimulation of isolated monocytes of critically ill patients with Pseudomonas aeruginosa sepsis with LPS

  four years

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients with sepsis with microbiologically proven infection with Pseudomonas aeruginosa

You may qualify if:

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

You may not qualify if:

• life expectancy \< 24 hours
• participation in other studies

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

Clinic of Anesthesiology

Ulm, 89070, Germany

RECRUITING

Related Publications (4)

• Brunialti MK, Santos MC, Rigato O, Machado FR, Silva E, Salomao R. Increased percentages of T helper cells producing IL-17 and monocytes expressing markers of alternative activation in patients with sepsis. PLoS One. 2012;7(5):e37393. doi: 10.1371/journal.pone.0037393. Epub 2012 May 31.

  PMID: 22693573 BACKGROUND

• Hotchkiss RS, Karl IE. The pathophysiology and treatment of sepsis. N Engl J Med. 2003 Jan 9;348(2):138-50. doi: 10.1056/NEJMra021333. No abstract available.

  PMID: 12519925 BACKGROUND

• Mantovani A, Sica A, Locati M. New vistas on macrophage differentiation and activation. Eur J Immunol. 2007 Jan;37(1):14-6. doi: 10.1002/eji.200636910.

  PMID: 17183610 BACKGROUND

• Neu C, Sedlag A, Bayer C, Forster S, Crauwels P, Niess JH, van Zandbergen G, Frascaroli G, Riedel CU. CD14-dependent monocyte isolation enhances phagocytosis of listeria monocytogenes by proinflammatory, GM-CSF-derived macrophages. PLoS One. 2013 Jun 11;8(6):e66898. doi: 10.1371/journal.pone.0066898. Print 2013.

  PMID: 23776701 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, plasma

MeSH Terms

Conditions

Pseudomonas Infections; Pneumonia; Sepsis; Critical Illness

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Manfred Weiss, MD, MBA

  University Ulm, University Hospital Ulm

  PRINCIPAL INVESTIGATOR

• Anne Sedlag, Biochemist

  University Ulm, Institute of Microbiology and Biotechnology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manfred Weiss, MD, MBA

CONTACT

+49 731 500 60226; manfred.weiss@uniklinik-ulm.de

Eberhard Barth, MD

CONTACT

+49 731 500 60050; eberhard.barth@uniklinik-ulm.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 6, 2017
• Study Start: August 1, 2014
• Primary Completion: November 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)