Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID05266092

Activation of the Contact System and the Immune System in Patients With Chronic Kidney Disease

Led by Odense University Hospital · Updated on 2022-11-15

400

Participants Needed

1

Research Sites

469 weeks

Total Duration

On this page

Sponsors

O

Odense University Hospital

Lead Sponsor

U

University of Southern Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research investigates how patients with chronic kidney disease (CKD) undergoing hemodialysis (HD) are affected by bloodstream infections, particularly those caused by Staphylococcus aureus. HD patients face a very high risk of death, especially early after infection, largely due to cardiovascular problems and infections like endocarditis. The study aims to understand how HD may weaken the immune response and promote blood clotting that supports bacterial growth, increasing infection risks. The study collects blood samples from four groups: CKD patients on hemodialysis, CKD patients not on dialysis, CKD patients on peritoneal dialysis, and healthy volunteers. Blood plasma is analyzed before and after HD sessions to measure inflammation and coagulation markers. The study compares these levels across groups to explore the effects of HD on immune activity and blood clotting. Participants will provide blood samples at enrollment and during HD sessions. Researchers will measure plasma levels of activated contact system markers, especially cHK, to assess immune and coagulation status. The study focuses on understanding blood changes related to infections and clotting in CKD and dialysis patients. Participation involves blood draws and health assessments, with data collected to improve knowledge about infection risks and immune function in this population.

CONDITIONS

Brief Title

Activation of the Contact System and the Immune System in Patients With Chronic Kidney Disease.

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Diagnosis of chronic kidney disease
  • For hemodialysis group: currently undergoing hemodialysis
  • For non-dialysis group: eGFR between less than 15 to 44 and not on dialysis
  • For peritoneal dialysis group: currently undergoing peritoneal dialysis
  • For healthy volunteers: blood donors aged over 18 years
Not Eligible

You will not qualify if you...

  • Acute kidney disease
  • For non-dialysis group: undergoing hemodialysis or peritoneal dialysis

AI-Screening

AI-Powered Screening

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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)

Diagnostic Evaluation

Duration - At enrollment

Participants undergo assessments including blood sampling to measure plasma levels related to chronic kidney disease.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 9 years

Participants are observed over time to monitor the activation of the contact system and immune system without receiving any intervention.

Visits as per routine clinical care

Trial Site Locations

Total: 1 location

1

Odense University Hospital

Odense, Denmark, 5230

Actively Recruiting

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Research Team

K

Katrine Pilely, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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