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

Not Applicable

Completed

• Conditions: Coronary Arteriosclerosis; Valve Heart Disease
• Interventions: Procedure: Heart-Lung-Machine

• Registration Number: NCT04598360
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-22
• Study Start: 2020-11-01
• Primary Completion: 2021-09-01
• Study Completion: 2022-01-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Erythrocyte Fatty-Acid Status	Heart-Lung-Machine	Erythrocyte Fatty-Acid Status Profiling of cardiac surgery patients are studied before and during heart-lung-machine procedure using LC-MS / MS

Primary Outcome Measures

Name	Time	Method
Coefficient of variation of relative quantities of erythrocyte fatty-acid parameters related to its dynamic during HLM, using LC-MS / MS.	4-5months	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.

Trial Locations

Locations (1)

Charité University Experimental & Clinical Research Center; 🇩🇪 Berlin, Germany