Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05957146
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2023-07-04
Brief Title:
Kinetics of Extracellular Vesicles in Hemodialysis
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Kinetics of Extracellular Vesicles in Hemodialysis
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this observational study is to gain insight into the kinetics of extracellular vesicles EVs derived from both in- ie 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
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
Detailed 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 anor injury so called extracellular vesicles EVs These EVs which are shed by various cell types upon activation andor 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
Various cell types shed small particles upon activation anor injury so called extracellular vesicles EVs These EVs which are shed by various cell types upon activation andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None