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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Denmark
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Katrine Pilely, PhD
kapi@sdu.dk
0045 20963328
Time Frame
Start Date: 2022-04-25
Estimated Completion Date: 2032-04
Participants
Target number of participants: 400
Treatments
Participants with chronic kidney disease undergoing hemodialysis
Participants with chronic kidney disease, not in dialysis
Participants with chronic kidney disease undergoing peritoneal dialysis
Healthy participants
Related Therapeutic Areas
Sponsors
Leads: Odense University Hospital
Collaborators: University of Southern Denmark

This content was sourced from clinicaltrials.gov