N18.5
Conditions
Interventions
Group 1: Hypervolemic hemodialysis patients (group H)
Group 2: Normovolemic hemodialysis patients (group N)
Sponsors
Universitätsklinikum Halle / Klinik für Innere Medizin II
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - endstage renal disease since 3 months - ultrafiltration rate per hemodialysis session > 2000 ml
Exclusion criteria
Exclusion criteria: - missing informed consent or cooperation - known malignancy - acute infection (CRP > 50mg/l, fever, chills) - psychiatric or neurologic diseases, which influence ability of informed consent - known pregnancy or inadequat contraception (in premenopausal women)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A = 45% increase in the IL-10 transcription rate of monocytes and lymphocytes in hypervolemic patients is defined as the primary endpoint. There is only one assessment point (1 blood sample after the long dialysis-free interval before the start of dialysis) at which the absolute values ??of both groups H vs. N are compared. Our hypothesis assumes an increase in the IL-10 transcription rate in the hypervolemic patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints to be analyzed between the hypervolemic (H) and normovolemic (N) groups to be examined are: - the relative displacement of regulatory T-cells - the relative shift of TNF-a and IL-10 producing cells (Th1 / Th2) - different IL-10 miRNA levels in the serum of hyper- and normovolemics - different IL-10 miRNA content in exosomes of hyper- and normovolemics | — |
Countries
Germany
Contacts
Public ContactRoman Fiedler
Universitätsklinikum Halle / KfH Nierenzentrum
Outcome results
None listed