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

Recruiting

• Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
• Interventions: Other: Observational study

• Registration Number: NCT05266092
• Lead Sponsor: Odense University Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-03-04
• Study Start: 2022-04-25
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-15
• Primary Completion: 2023-04
• Study Completion: 2032-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with chronic kidney disease undergoing peritoneal dialysis	Observational study	-
Participants with chronic kidney disease, not in dialysis	Observational study	-
Participants with chronic kidney disease undergoing hemodialysis	Observational study	-
Healthy participants	Observational study	-

Primary Outcome Measures

Name	Time	Method
Plasma level of cHK	At enrollment	cHK is the final activation product of the contact activation system

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark