Release of Epoxyeicosatrienoic Acids From Erythrocytes During the Use of Extracorporeal Procedures (Heart-lung Machine)

Coronary Arteriosclerosis Clinical Trial

Official title:

A Lipidomics Study: Release of Epoxyeicosatrienoic Acids From Erythrocytes During the Use of Extracorporeal Procedures (Heart-lung Machine)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04598360
• Other study ID #: EA2/113/08
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: January 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 heart-lung-machine. 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 HLM arise. In this project the hypothesis will be checked, if EETs / DHETs are released by Erythrocytes during this extracorporeal procedure and thus act as potential candidate products for the result of hypotonic phases during usage of heart-lung-machine.

We will determine differences in RBC fatty acids profiling in patients before and after heart-lung-machine intervention. RBC fatty acids profiling will be achieved by using targeted HPLC-MS mass spectrometry.

It is believed that during HLM 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients who are undergoing an operation with the aid of the heart-lung machine for cardiac surgery

• Age over 18 years

• Ability to consent

• There is a written consent of the study participant

Exclusion Criteria:

•none

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Heart Diseases
• Heart Valve Diseases
• Myocardial Ischemia
• Valve Heart Disease

Intervention

Procedure:
• Heart-Lung-Machine
blood sample before and during a single Heart-Lung-Machine procedure

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

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 HLM, 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.	4-5months