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

Primary Purpose

Coronary Arteriosclerosis, Valve Heart Disease

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Heart-Lung-Machine

About this trial

This is an interventional basic science trial for Coronary Arteriosclerosis focused on measuring Fatty Acid Metabolism, Erythrocytes, Lipidomics, Heart-Lung-Machine

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Charité University Experimental & Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Erythrocyte Fatty-Acid Status

Arm Description

Erythrocyte Fatty-Acid Status Profiling of cardiac surgery patients are studied before and during heart-lung-machine procedure using LC-MS / MS

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04598360

First Posted

October 16, 2020

Last Updated

March 8, 2022

Sponsor

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT04598360

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

November 1, 2020 (Actual)

Primary Completion Date

September 1, 2021 (Actual)

Study Completion Date

January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Arteriosclerosis, Valve Heart Disease

Keywords

Fatty Acid Metabolism, Erythrocytes, Lipidomics, Heart-Lung-Machine

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Erythrocyte Fatty-Acid Status

Arm Type

Experimental

Arm Description

Erythrocyte Fatty-Acid Status Profiling of cardiac surgery patients are studied before and during heart-lung-machine procedure using LC-MS / MS

Intervention Type

Procedure

Intervention Name(s)

Heart-Lung-Machine

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

4-5months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Charité University Experimental & Clinical Research Center

City

Berlin

ZIP/Postal Code

13125

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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