Hemodialysis and Erythrocyte Fatty-Acid Status: a Lipidomics Study
1 other identifier
interventional
30
1 country
1
Brief Summary
Hypotension with potentially serious consequences for organ perfusion is a common complication in extracorporeal procedures such as hemodialysis / hemofiltration. The exact reasons for this are still insufficiently clarified. Probably periinterventional vasorelaxant released substances play a crucial role in these procedures. These substances could be due to contact of blood cells with the Membrane in the dialyzer / hemofilter arise. In this project the hypothesis will be checked, if EETs / DHETs are released by Erythrocytes during hemodialysis and thus act as potential candidate products for the result of hypotonic phases in the Dialysis. We will determine differences in RBC fatty acids profiling in hemodialysis patients before and after dialysis intervention. Furthermore a matched control group of healthy individuals will be profiled. RBC fatty acids profiling will be achieved by using targeted HPLC-MS mass spectrometry. It is believed that during hemodialysis / HLM / CVVH there is an increase in EETs / DHETs in the serum and in the erythrocytes. It is believed that shear forces play an important role in the release of erythrocyte EETs / DHETs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 24, 2019
CompletedFirst Posted
Study publicly available on registry
February 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedMarch 10, 2022
March 1, 2022
3.7 years
February 24, 2019
March 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Coefficient of variation of relative quantities of erythrocyte fatty-acid parameters related to its dynamic during Hemodialysis, using LC-MS / MS.
EETs / DHETs will be analyzed in the erythrocytes and serum of the recovered blood samples. The determination will made in cooperation with a Berliner Biotech company. This involves liquid chromatography with MS coupling (LC-MS / MS) used. The data analysis is carried out by means of suitable statistical methods to perform erythrocyte fatty-acid status profiling.
4-5 Months
Study Arms (1)
Erythrocyte Fatty-Acid Status
EXPERIMENTALErythrocyte Fatty-Acid Status Profiling of HD patients are studied before and after a single HD using LC-MS / MS
Interventions
Eligibility Criteria
You may qualify if:
- Patients who have a history of renal failure and undergo hemodialysis / hemofiltration
- Age over 18 years
- Ability to consent
- There is a written consent of the study participant
You may not qualify if:
- chronic illness requiring any medication
- pregnancy
- limitations regarding functioning in the hypoxic chamber
- inability to follow simple instructions relevant or severe abnormalities in medical history, physical examination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charité University Experimental & Clinical Research Center
Berlin, 13125, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 24, 2019
First Posted
February 28, 2019
Study Start
May 1, 2018
Primary Completion
January 1, 2022
Study Completion
February 1, 2022
Last Updated
March 10, 2022
Record last verified: 2022-03