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Completed

NCT Number: NCT03857984

Hemodialysis and Erythrocyte Fatty-Acid Status: a Lipidomics Study

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.

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Key information

Conditions

Fatty Acid Metabolism Erythrocytes Hemodialysis Lipidomics

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité University Experimental & Clinical Research Center

Berlin, 13125, Germany

About this study

Differences in Erythrocyte Fatty-Acid Status Profiling in:

  • before and after hemodialysis intervention
  • in hemodialysis patients and healthy individuals Venous blood will be collected from each subject in the sitting position

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for hemodialysis patients:

  • 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

Exclusion criteria

for healthy control group:

  • 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

Treatment and study plan

Blood sampling

Other

blood sample before and after a single HD

Primary outcomes

  1. Coefficient of variation of relative quantities of erythrocyte fatty-acid parameters related to its dynamic during Hemodialysis, using LC-MS / MS.

    Time frame: 4-5 Months

    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.

Sponsors and collaborators

Lead sponsor

Benjamin Gollasch

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2019
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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