AKIM-CKD: Activation of the Contact System and the Immune System in Patients With Chronic Kidney Disease.

Sponsor

Odense University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05266092

Collaborator

University of Southern Denmark (Other)

400

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Requiring Chronic Dialysis	Other: Observational study

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Participants with chronic kidney disease undergoing hemodialysis	Other: Observational study Observational study
Participants with chronic kidney disease, not in dialysis	Other: Observational study Observational study
Participants with chronic kidney disease undergoing peritoneal dialysis	Other: Observational study Observational study
Healthy participants	Other: Observational study Observational study

Outcome Measures

Primary Outcome Measures

Plasma level of cHK [At enrollment]
cHK is the final activation product of the contact activation system

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Odense University Hospital
University of Southern Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Katrine Pilely, Postdoc, Odense University Hospital

ClinicalTrials.gov Identifier:

NCT05266092

Other Study ID Numbers:

OP_1579

First Posted:

Mar 4, 2022

Last Update Posted:

Apr 26, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Katrine Pilely, Postdoc, Odense University Hospital

Chronic kidney disease

Hemodialysis

End-stage renal disease

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Apr 26, 2022