Actively Recruiting
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
Eligibility Criteria
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
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
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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