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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-25

Study Completion Date

2032-04-30

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).

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Detailed Description

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Conditions

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Chronic Kidney Disease Requiring Chronic Dialysis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with chronic kidney disease undergoing hemodialysis

Observational study

Intervention Type OTHER

Observational study

Participants with chronic kidney disease, not in dialysis

Observational study

Intervention Type OTHER

Observational study

Participants with chronic kidney disease undergoing peritoneal dialysis

Observational study

Intervention Type OTHER

Observational study

Healthy participants

Observational study

Intervention Type OTHER

Observational study

Interventions

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Observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years
* Chronic kidney disease
* Hemodialysis

* Age \>18 years
* Chronic kidney disease (eGFR from \<15 to 44)

* Age \>18 years
* Chronic kidney disease
* Peritoneal dialysis

* Age \>18 years
* Blooddonors