Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05957146 |
Other study ID # |
NL84115.018.23 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 2023 |
Est. completion date |
August 2024 |
Study information
Verified date |
July 2023 |
Source |
Amsterdam UMC, location VUmc |
Contact |
Muriel PC Grooteman, MD PhD |
Phone |
+3120 566 5990 |
Email |
mpc.grooteman[@]amsterdamumc.nl |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The aim of this observational study is to gain insight into the kinetics of extracellular
vesicles (EVs), derived from both in- (i.e. bio-incompatibility) and outside (tissue-injury)
the extracorporeal circuit (ECC), during standard hemodialysis (HD) in adult prevalent
end-stage kidney disease (ESKD) patients treated with HD.
During a single HD session, blood samples for EV-assessment will be taken at several time
points and at different sampling sites in the extracorporeal circuit (sampling point 1:
before the rollerpump, arterial line; sampling point 2: after the rollerpump and before the
dialyzer, sampling point 3: after the dialyzer, efferent line).
Description:
Hemodialysis (HD) is a lifesaving treatment for ESKD patients. Yet, apart from beneficial
effects, HD has adverse consequences, which, apart from rapid osmolality and electrolyte
shifts, results from the bio-incompatibility (BI) of the extra-corporeal circuit (ECC) and
intradialytic hypotension (IDH) as well. While BI arises within the ECC due to the contact
between circulating blood cells and the foreign materials of the lines and dialyzer,
IDH-induced tissue injury (TI) originates within the body of the patients. Activated cells
can be detected by upregulation of cell surface markers and release of degradation products.
Substances which are smaller than the pores of dialyzer-membranes may pass this barrier and,
thus, become undetectable in blood.
Various cell types shed small particles upon activation an/or injury, so called extracellular
vesicles (EVs). These EVs, which are shed by various cell types upon activation and/or
injury, contain various proteins and are too large to travers dialyzer membranes. Their
assessment requires strict and standardized collection and handling of blood samples. In
previous HD research, both pre-analytical circumstances and analytic methods were
insufficiently standardized, precluding solid conclusions. Both the contact between
circulating blood cells and the ECC, and recurrent IDH, predispose to micro-inflammation and
cell activation, which are related to morbidity and mortality. Hence, when analysed properly,
the measuring of EVs might be a valuable tool to assess dialysis-induced adverse
side-effects, not only in the dialyzer but also in the body, which, when occurring
repeatedly, may influence survival.
In a recent study, we found an increase in EVs during treatment with different dialysis
modalities. However, EVs were only assessed before and after dialysis. Hence, in the present
study, we aim to assess the kinetics of EVs in routine HD.