Actively Recruiting

Age: 18Years - 90Years
All Genders
Healthy Volunteers
ID03044223

Phenotypical and Functional Characterization of Macrophages in Critically Ill Patients With Pseudomonas Aeruginosa Induced Sepsis

Led by University of Ulm · Updated on 2024-01-17

100

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand the immune response in critically ill patients with sepsis caused by Pseudomonas aeruginosa (PSA). It focuses on whether the pro-inflammatory (M1) or anti-inflammatory (M2) type of monocytes dominate in the blood and how this relates to the severity of the sepsis and the patient's outcome. The study builds on previous findings that anti-inflammatory monocytes may be more common in sepsis but seeks to explore this further specifically for PSA infections. The study collects blood samples from critically ill patients in intensive care units who have confirmed PSA infections. Researchers analyze monocytes by measuring specific surface markers using flow cytometry and assess cytokine patterns both in the patients and after stimulating the cells outside the body with lipopolysaccharide (LPS). This helps to characterize the types and functions of monocytes present during PSA sepsis. Participants have their blood drawn to isolate immune cells for testing and comparison with healthy controls. Researchers monitor monocyte surface markers and cytokine levels over time. The main outcome is measuring monocyte surface marker expression over two years, while secondary outcomes include cytokine concentration changes after stimulation over four years. This observational study helps to clarify immune cell behavior during PSA sepsis and may guide future treatments.

CONDITIONS

Brief Title

Monocyte Profiles in Critically Ill Patients With Pseudomonas Aeruginosa Sepsis

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Critically ill patients diagnosed with sepsis
  • Confirmed microbiological infection with Pseudomonas aeruginosa
Not Eligible

You will not qualify if you...

  • Life expectancy less than 24 hours
  • Participation in other clinical studies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

Duration - Up to 4 years

Participants provide blood samples to analyze monocyte and macrophage profiles related to Pseudomonas aeruginosa sepsis.

Multiple blood collection visits over the study period

Long-term Monitoring

Duration - Up to 4 years

Participants are observed for changes in monocyte surface marker expression and cytokine production over time.

Periodic visits for sample collection and assessments

Trial Site Locations

Total: 1 location

1

Clinic of Anesthesiology

Ulm, Germany, 89070

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Research Team

M

Manfred Weiss, MD, MBA

E

Eberhard Barth, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Increased percentages of T helper cells producing IL-17 and monocytes expressing markers of alternative activation in patients with sepsis.

Milena Karina Colo Brunialti, Michelle Carolina Santos, Otelo Rigato...

https://pubmed.ncbi.nlm.nih.gov/22693573

CD14-dependent monocyte isolation enhances phagocytosis of listeria monocytogenes by proinflammatory, GM-CSF-derived macrophages.

Caroline Neu, Anne Sedlag, Carina Bayer...

https://pubmed.ncbi.nlm.nih.gov/23776701