Potential immune-mechanisms of hypervolemia in hemodialysis patients: oxidative stress and exosomal IL-1ß

Recruiting

• Conditions: N18.5; Chronic kidney disease, stage 5

• Registration Number: DRKS00017438
• Lead Sponsor: niversitätsklinikum Halle, Klinik für Innere Klinik II, KfH Nierenzentrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

age >18 years
- endstage renal disease (treated with HD) for at least 3 months
- HD ultrafiltration > 2000 ml per session after long dialysis-free interval

Exclusion Criteria

- lack of consent / lack of cooperation
- known malignant tumor disease
- acute infection (CRP> 50mg / l, fever, chills)
- psychiatric or neurological disorders that affect the ability to consent
- known pregnancy or lack of contraception (premenopausal women)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint is defined to compare the amount of = 25% increase of CD16+ monocyte population in hypervolemic (group H) versus normovolemic (group N) HD patients between two hemodialysis sessions (long dialysis-free interval).

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints should be investigated between the two groups H and N:<br>- quantitative shift of monocyte subpopulations and decrease of myeloid suppressor cells<br>- change in concentration of oxidative stress (MitoROS)<br>- level of IL-1ß concentration<br>- activation of exosomes