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

NCT05266092 | Recruiting

• 1 other identifier: OP_1579
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

Contact system; Infection; Innate immune system; Coagulation; Chronic kidney disease; Hemodialysis; End-stage renal disease

Outcome Measures

Primary Outcomes (1)

• Plasma level of cHK

  cHK is the final activation product of the contact activation system

  At enrollment

Study Arms (4)

Participants with chronic kidney disease undergoing hemodialysis

Other: Observational study

Participants with chronic kidney disease, not in dialysis

Other: Observational study

Participants with chronic kidney disease undergoing peritoneal dialysis

Other: Observational study

Healthy participants

Other: Observational study

Interventions

Observational study OTHER

Observational study

Healthy participants; Participants with chronic kidney disease undergoing hemodialysis; Participants with chronic kidney disease undergoing peritoneal dialysis; Participants with chronic kidney disease, not in dialysis

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Blood samples and clinical information is collected from 180 participants with chronic kidney disease undergoing hemodialysis, before and after dialysis. Their levels of components from the innate immune system in plasma are compared to the levels in plasma samples from three control groups: 60 participants with chronic kidney disease not in dialysis, 60 participants with chronic kidney disease undergoing peritoneal dialysis and 120 healthy volunteers.

You may qualify if:

• Age \>18 years
• Chronic kidney disease
• Hemodialysis

You may not qualify if:

• \- Acute kidney disease
• Age \>18 years
• Chronic kidney disease (eGFR from \<15 to 44)
• Acute kidney disease
• Hemodialysis
• Peritoneal dialysis
• Age \>18 years
• Chronic kidney disease
• Peritoneal dialysis
• \- Acute kidney disease
• Age \>18 years
• Blooddonors
• \- NA

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5230, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for collecting citrated and EDTA plasma

MeSH Terms

Conditions

Infections; Thrombosis; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

Observation

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Katrine Pilely, PhD

CONTACT

0045 20963328; kapi@sdu.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 4, 2022
• Study Start: April 25, 2022
• Primary Completion: April 1, 2023
• Study Completion (Estimated): April 1, 2032
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)