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

Study Overview
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Brief Summary
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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).

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

Conditions
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Chronic Kidney Disease Requiring Chronic Dialysis

Intervention / Treatment
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* Other: Observational study


Participation Criteria
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Eligibility Criteria
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Participants with chronic kidney disease undergoing hemodialysis Inclusion criteria Age >18 years Chronic kidney disease Hemodialysis Exclusion criteria: - Acute kidney disease Participants with chronic kidney disease, not in dialysis Inclusion criteria Age >18 years Chronic kidney disease (eGFR from <15 to 44) Exclusion criteria: Acute kidney disease Hemodialysis Peritoneal dialysis Participants with chronic kidney disease undergoing peritoneal dialysis Inclusion criteria Age >18 years Chronic kidney disease Peritoneal dialysis Exclusion criteria: - Acute kidney disease Healthy volunteers Inclusion criteria Age >18 years Blooddonors Exclusion criteria: - NA

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with chronic kidney disease undergoing hemodialysis<br> | Other: Observational study<br>* Observational study<br>|
| Participants with chronic kidney disease, not in dialysis<br> | Other: Observational study<br>* Observational study<br>|
| Participants with chronic kidney disease undergoing peritoneal dialysis<br> | Other: Observational study<br>* Observational study<br>|
| Healthy participants<br> | Other: Observational study<br>* Observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma level of cHK | cHK is the final activation product of the contact activation system | At enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact system, Infection, Innate immune system, Coagulation, Chronic kidney disease, Hemodialysis, End-stage renal disease