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Completed

NCT Number: NCT04598360

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

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.

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Key information

Conditions

Coronary Arteriosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Valve Heart Disease Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité University Experimental & Clinical Research Center

Berlin, 13125, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Heart-Lung-Machine

Procedure

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

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 22, 2020
Registry last updated
Mar 22, 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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