Hemodialysis and Erythrocyte Fatty-Acid Status: a Lipidomics Study

Hemodialysis Clinical Trial

Official title:

Hemodialysis and Erythrocyte Fatty-Acid Status: a Lipidomics Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03857984
• Other study ID #: E2/113/08
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: February 1, 2022

Study information

• Verified date: March 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Erythrocytes
• Fatty Acid Metabolism
• Hemodialysis
• Lipidomics

Intervention

Other:
• Blood sampling
blood sample before and after a single HD

Locations

Country	Name	City	State
Germany	Charité University Experimental & Clinical Research Center	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Benjamin Gollasch

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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