Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT05266092

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

518 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

Patients with end-stage renal disease undergoing hemodialysis (HD) are burdened with extremely high mortality rates (15% per year) and during the early stage (≤120days) the mortality rate is even higher (27% per year). Cardiovascular complications and bloodstream infections (BSIs) account for the vast majority of deaths in HD patients. In Denmark, BSIs occur in 14% of HD patients per year and is most frequently caused by Staphylococcus aureus (44%). The most frequent infectious complication is endocarditis that has fatal outcomes in ≈50% of the cases. Overall, 10% of HD patients die within 30 days after a positive blood culture for S. aureus. This project aims to answer key questions regarding HD patients' decreased ability to fight S. aureus BSIs and in particular the potential exacerbating effect of HD. We hypothesize that HD patients' blood is significantly compromised by the process of HD, to an extend that lowers immunoactivity against S. aureus. Moreover, we hypothesize, that contact activation promotes the coagulability of blood thus promoting biofilm formation by S. aureus which increases the overall risk of BSI. We will test these hypotheses by collecting blood and analyzing the inflammation and coagulation status in plasma samples from participants before and after HD. We will compare the level of the inflammatory markers in plasma from participants undergoing HD (n=180) to the level in plasma samples from three control groups: healthy volunteers (n=120), participants with renal disease not in dialysis (n=60) and participants undergoing peritoneal dialysis (n=40).

CONDITIONS

Official 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 >18 years
  • Chronic kidney disease
  • Hemodialysis
  • Age >18 years
  • Chronic kidney disease (eGFR from <15 to 44) and not in dialysis
  • Age >18 years
  • Chronic kidney disease
  • Peritoneal dialysis
  • Age >18 years
  • Healthy blood donors
Not Eligible

You will not qualify if you...

  • Acute kidney disease
  • Acute kidney disease
  • Hemodialysis
  • Peritoneal dialysis
  • Acute kidney disease
  • NA

AI-Screening

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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

CONTACT

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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