Activation of the Contact System and the Immune System in Patients With Chronic Kidney Disease.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational study.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease Requiring Chronic Dialysis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Activation of the Contact System and the Immune System in Patients With Chronic Kidney
Overview
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).
Interventions
- Other Observational study
Observational study
Primary outcome measures
- Plasma level of cHK [Time frame: At enrollment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Denmark · 1 center
- Odense University Hospital — Odense
Identifiers
NCT: NCT05266092 · OP_1579