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

Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial

— AKIM-CKD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05266092
• Other study ID #: OP_1579
• Status: Recruiting
• Start date: April 25, 2022
• Est. completion date: April 2032

Study information

• Verified date: November 2022
• Source: Odense University Hospital
• Contact: Katrine Pilely, PhD
• Phone: 0045 20963328
• Email: kapi[@]sdu.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2032
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Observational study
Observational study

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma level of cHK	cHK is the final activation product of the contact activation system	At enrollment